{"id":"sodium-fluoride-f-18","rwe":[{"pmid":"29999764","year":"2006","title":"Sodium Fluoride F 18.","finding":"","journal":"","studyType":"Clinical Study"},{"pmid":"28441368","year":"2017","title":"Skeletal Scintigraphy.","finding":"","journal":"Cancer control : journal of the Moffitt Cancer Center","studyType":"Clinical Study"},{"pmid":"25208282","year":"2014","title":"Newer PET application with an old tracer: role of 18F-NaF skeletal PET/CT in oncologic practice.","finding":"","journal":"Radiographics : a review publication of the Radiological Society of North America, Inc","studyType":"Clinical Study"},{"pmid":"23013185","year":"2012","title":"Assessment of blood pool, soft tissue, and skeletal uptake of sodium fluoride F 18 with positron emission tomography-computed tomography in four clinically normal dogs.","finding":"","journal":"American journal of veterinary research","studyType":"Clinical Study"},{"pmid":"14672356","year":"2003","title":"F-18 NaF PET for detection of bone metastases in lung cancer: accuracy, cost-effectiveness, and impact on patient management.","finding":"","journal":"Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research","studyType":"Clinical Study"}],"_fda":{"id":"d951aa31-f016-e2da-e053-2995a90a5b2d","set_id":"2144e4e4-4be5-4fc6-b966-bd525ac7e430","openfda":{"unii":["9L75099X6R"],"route":["INTRAVENOUS"],"spl_id":["d951aa31-f016-e2da-e053-2995a90a5b2d"],"brand_name":["Sodium Fluoride F 18"],"spl_set_id":["2144e4e4-4be5-4fc6-b966-bd525ac7e430"],"package_ndc":["67939-020-10"],"product_ndc":["67939-020"],"generic_name":["SODIUM FLUORIDE F 18"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["SODIUM FLUORIDE F-18"],"manufacturer_name":["The University of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer Institute"],"application_number":["ANDA204497"],"is_original_packager":[true]},"version":"8","pregnancy":["8.1 Pregnancy Pregnancy Category C Any radiopharmaceutical including Sodium Fluoride F 18 Injection has a potential to cause fetal harm. The likelihood of fetal harm depends on the stage of fetal development, and the radionuclide dose. Animal reproductive and developmental toxicity studies have not been conducted with Sodium Fluoride F 18 Injection. Prior to the administration of Sodium Fluoride F 18 Injection to women of childbearing potential, assess for presence of pregnancy. Sodium Fluoride F 18 Injection should be given to a pregnant woman only if clearly needed."],"references":["15 REFERENCES Stabin, M.G., Stubbs, J.B. and Toohey R.E., Radiation Dose Estimates for Radiopharmaceuticals, U.S. Nuclear Regulatory Commission report NUREG/CR-6345, page 10, 1996. Radiation Dose to Patients from Radiopharmaceuticals, ICRP publication 53, Ann ICRP, 18 pages 15 and 74, 1987 Kocher, D.C., \"Radioactive Decay Data Tables: A Handbook of decay data for application to radiation dosimetry and radiological assessments\" DOE/TIC-11026, page 69, 1981."],"description":["11 DESCRIPTION 11.1 Chemical Characteristics Sodium Fluoride F 18 Injection, USP is a positron emitting radiopharmaceutical, containing no-carrier-added, radioactive fluoride F18 that is used for diagnostic purposes in conjunction with PET imaging. It is administered by intravenous injection. The active ingredient, sodium fluoride F18, has the molecular formula Na[18F] with a molecular weight of 40.99, and has the following chemical structure: Na+ 18 F – Sodium Fluoride F 18 Injection, USP is provided as a ready-to-use, isotonic, sterile, pyrogen-free, preservative-free, clear and colorless solution. Each mL of the solution contains between 370 MBq to 7,400 MBq (10 mCi to 200 mCi) sodium fluoride F18, at the EOS reference time, in 0.9% aqueous sodium chloride. The pH of the solution is between 4.5 and 8. The solution is presented in 30 mL multiple- dose glass vials with a total volume of approximately 8 to 10 mL and total radioactivity containing between 2,960 MBq to 74,000 MBq (80 to 2,000 mCi) in each vial. 11.2 Physical Characteristics Fluoride F18 decays by positron (β+) emission and has a half-life of 109.7 minutes. Ninety-seven percent of the decay results in emission of a positron with a maximum energy of 633 keV and 3% of the decay results in electron capture with subsequent emission of characteristic X-rays of oxygen. The principal photons useful for diagnostic imaging are the 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron (Table 2). Fluorine F18 atom decays to stable 18 O-oxygen. Table 2: Principal Emission Data for Fluoride F18 Radiation/Emission % per Disintegration Mean Energy Positron (β+) 96.73 249.8 keV Gamma (±)* 193.46 511.0 keV * Produced by positron annihilation [3] Kocher, D.C. Radioactive Decay Data Tables DOE/TIC-11026, 69, 1981. The specific gamma ray constant for fluoride F18 is 5.7 R/hr/mCi (1.35 x 10 -6 Gy/hr/kBq) at 1 cm. The half-value layer (HVL) for the 511 keV photons is 4.1 mm lead (Pb). A range of values for the attenuation of radiation results from the interposition of various thickness of Pb. The range of attenuation coefficients for this radionuclide is shown in Table 3. For example, the interposition of an 8.3 mm thickness of Pb with a coefficient of attenuation of 0.25 will decrease the external radiation by 75%. Table 3:Radiation Attenuation of 511 keV Photons by Lead (Pb) Shielding Shield Thickness (Pb) mm Coefficient of Attenuation 0 0.00 4 0.50 8 0.25 13 0.10 26 0.01 39 0.001 52 0.0001 Table 4 lists the fraction of radioactivity remaining at selected time intervals from the calibration time. This information may be used to correct for physical decay of the radionuclide. Table 4: Physical Decay Chart for Fluoride F18 Time Since Calibration Fraction Remaining 0* 1.00 15 minutes 0.909 30 minutes 0.826 60 minutes 0.683 110 minutes 0.500 220 minutes 0.250 440 minutes 0.060 12 hours 0.011 24 hours 0.0001 * Calibration time"],"pediatric_use":["8.4 Pediatric Use In reported clinical experience in approximately 100 children, weight based doses (2.1 MBq/kg) ranging from 19 MBq–148 MBq (0.5 mCi - 4 mCi) were used. Sodium Fluoride F18 was shown to localize to areas of bone turnover including rapidly growing epiphyses in developing long bones. Children are more sensitive to radiation and may be at higher risk of cancer from Sodium Fluoride F18 injection."],"effective_time":"20220303","nursing_mothers":["8.3 Nursing Mothers It is not known whether Sodium Fluoride F 18 Injection is excreted into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of Sodium Fluoride F 18 Injection or not to administer Sodium Fluoride F 18 Injection, taking into account the importance of the drug to the mother. The body of scientific information related to radioactivity decay, drug tissue distribution and drug elimination shows that less than 0.01% of the radioactivity administered remains in the body after 24 hours (10 half-lives). To minimize the risks to a nursing infant, interrupt nursing for at least 24 hours."],"clinical_studies":["14 CLINICAL STUDIES 14.1 Metastatic Bone Disease The doses used in reported studies ranged from 2.7 mCi to 20 mCi (100 MBq to 740 MBq), with an average median dose of 10 mCi (370 MBq) and an average mean dose of 9.2 mCi (340 MBq). In PET imaging of bone metastases with Sodium Fluoride F 18 Injection, focally increased tracer uptake is seen in both osteolytic and osteoblastic bone lesions. Negative PET imaging results with Sodium Fluoride F 18 Injection do not preclude the diagnosis of bone metastases. Also, as benign bone lesions are also detected by Sodium Fluoride F 18 Injection, positive PET imaging results cannot replace biopsy to confirm a diagnosis of cancer. 14.2 Other Bone Disorders The doses used in reported studies ranged from 2.43 mCi to 15 mCi (90 MBq to 555 MBq), with an average median dose of 8.0 mCi (300 MBq) and an average mean dose of 7.6 mCi (280 MBq)."],"pharmacodynamics":["12.2 Pharmacodynamics Increased fluoride F18 ion deposition in bone can occur in areas of increased osteogenic activity during growth, infection, malignancy (primary or metastatic) following trauma, or inflammation of bone."],"pharmacokinetics":["12.3 Pharmacokinetics After intravenous administration, fluoride F18 ion is rapidly cleared from the plasma in a biexponential manner. The first phase has a half-life of 0.4 h, and the second phase has a half-life of 2.6 h. Essentially all the fluoride F18 that is delivered to bone by the blood is retained in the bone. One hour after administration of fluoride, F18 only about 10% of the injected dose remains in the blood. Fluoride F18 diffuses through capillaries into bone extracellular fluid space, where it becomes bound by chemisorption at the surface of bone crystals, preferentially at sites of newly mineralizing bone. Deposition of fluoride F18 in bone appears to be primarily a function of blood flow to the bone and the efficiency of the bone in extracting the fluoride F18. Fluoride F18 does not appear to be bound to serum proteins. In patients with normal renal function, 20% or more of the fluorine ion is cleared from the body in the urine within the first 2 hours after intravenous administration."],"adverse_reactions":["6 ADVERSE REACTIONS No adverse reactions have been reported for Sodium Fluoride F 18 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known. No adverse reactions have been reported for Sodium Fluoride F 18 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems (6). To report SUSPECTED ADVERSE REACTIONS, contact The University of Utah DBA Cyclotron Radiochemistry Lab Hunstman Cancer Institute at 1-801-581-8745 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch."],"contraindications":["4 CONTRAINDICATIONS None. None (4)."],"description_table":["<table ID=\"ibd18b5d5-9c42-4564-8865-494e082cebc5\"><caption>Table 2: Principal Emission Data for Fluoride F18</caption><col width=\"141\"/><col width=\"117\"/><col width=\"117\"/><tbody><tr><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">Radiation/Emission</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">% per Disintegration</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">Mean Energy</td></tr><tr><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">Positron (&#x3B2;+)</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">96.73</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">249.8 keV</td></tr><tr><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">Gamma (&#xB1;)*</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">193.46</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">511.0 keV</td></tr></tbody></table>","<table ID=\"id6021e72-7fe5-4809-8880-7ad8c94e84ef\"><caption>Table 3:Radiation Attenuation of 511 keV Photons by Lead (Pb) Shielding</caption><col width=\"175\"/><col width=\"175\"/><tbody><tr><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">Shield Thickness (Pb) mm</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">Coefficient of Attenuation</td></tr><tr><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.00</td></tr><tr><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">4</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.50</td></tr><tr><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">8</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.25</td></tr><tr><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">13</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.10</td></tr><tr><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">26</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.01</td></tr><tr><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">39</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.001</td></tr><tr><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">52</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0001</td></tr></tbody></table>","<table ID=\"ib8b574c2-c9d0-4e89-849c-e6f270856ec2\"><caption>Table 4: Physical Decay Chart for Fluoride F18</caption><col width=\"175\"/><col width=\"216\"/><tbody><tr><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">Time Since Calibration</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">Fraction Remaining</td></tr><tr><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0*</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">1.00</td></tr><tr><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">15 minutes</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.909</td></tr><tr><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">30 minutes</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.826</td></tr><tr><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">60 minutes</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.683</td></tr><tr><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">110 minutes</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.500</td></tr><tr><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">220 minutes</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.250</td></tr><tr><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">440 minutes</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.060</td></tr><tr><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">12 hours</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.011</td></tr><tr><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">24 hours</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0001</td></tr></tbody></table>"],"drug_interactions":["7 DRUG INTERACTIONS The possibility of interactions of Sodium Fluoride F 18 Injection with other drugs taken by patients undergoing PET imaging has not been studied."],"mechanism_of_action":["12.1 Mechanism of Action Fluoride F18 ion normally accumulates in the skeleton in an even fashion, with greater deposition in the axial skeleton (e.g. vertebrae and pelvis) than in the appendicular skeleton and greater deposition in the bones around joints than in the shafts of long bones."],"storage_and_handling":["16 HOW SUPPLIED/STORAGE AND HANDLING Sodium Fluoride F 18 Injection, USP is supplied in a multiple-dose Type I glass vial with elastomeric stopper and aluminum crimp seal containing between 370 and 7,400 MBq/mL (10–200 mCi/mL) of no carrier-added sodium fluoride F18, at the EOS reference time, in aqueous 0.9% sodium chloride solution. The total volume is approximately 8 to 10 mL and total radioactivity per vial contains between 2,960 MBq to 74,000 MBq (80 to 2,000 mCi). Each vial is enclosed in a shielded container of appropriate thickness. The product is available in a 30 mL vial configuration with an approximate 8 to 10 mL fill volume. The NDC number is: 67939-020-10 Storage Store at 25°C (77°F) in a shielded container; excursions permitted to 15–30°C (59–86°F). Use the solution within 10 hours of the EOS reference time. Handling Receipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States as appropriate."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Fluoride F18 ion normally accumulates in the skeleton in an even fashion, with greater deposition in the axial skeleton (e.g. vertebrae and pelvis) than in the appendicular skeleton and greater deposition in the bones around joints than in the shafts of long bones. 12.2 Pharmacodynamics Increased fluoride F18 ion deposition in bone can occur in areas of increased osteogenic activity during growth, infection, malignancy (primary or metastatic) following trauma, or inflammation of bone. 12.3 Pharmacokinetics After intravenous administration, fluoride F18 ion is rapidly cleared from the plasma in a biexponential manner. The first phase has a half-life of 0.4 h, and the second phase has a half-life of 2.6 h. Essentially all the fluoride F18 that is delivered to bone by the blood is retained in the bone. One hour after administration of fluoride, F18 only about 10% of the injected dose remains in the blood. Fluoride F18 diffuses through capillaries into bone extracellular fluid space, where it becomes bound by chemisorption at the surface of bone crystals, preferentially at sites of newly mineralizing bone. Deposition of fluoride F18 in bone appears to be primarily a function of blood flow to the bone and the efficiency of the bone in extracting the fluoride F18. Fluoride F18 does not appear to be bound to serum proteins. In patients with normal renal function, 20% or more of the fluorine ion is cleared from the body in the urine within the first 2 hours after intravenous administration."],"indications_and_usage":["1 INDICATIONS AND USAGE Sodium Fluoride F 18 Injection, USP is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity. Sodium Fluoride F 18 Injection, USP is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity (1)."],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Allergic Reactions: As with any injectable drug product, allergic reactions and anaphylaxis may occur. Emergency resuscitation equipment and personnel should be immediately available (5.1). Cancer Risk: Sodium Fluoride F 18 Injection may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker (5.2). 5.1 Allergic Reactions As with any injectable drug product, allergic reactions and anaphylaxis may occur. Emergency resuscitation equipment and personnel should be immediately available. 5.2 Radiation Risks Sodium Fluoride F 18 Injection may increase the risk of cancer. Carcinogenic and mutagenic studies with Sodium Fluoride F18 injection have not been performed. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker [see Dosage and Administration (2.1)] ."],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Studies to assess reproductive toxicity, mutagenesis and carcinogenesis potential of Sodium Fluoride F 18 Injection have not been performed."],"information_for_patients":["17 PATIENT COUNSELING INFORMATION 17.1 Pre-study Hydration Encourage patients to drink at least 500 mL of water prior to drug administration. 17.2 Post-study Voiding To help protect themselves and others in their environment, patients should take the following precautions for 12 hours after injection: whenever possible, use a toilet and flush several times after each use; wash hands thoroughly after each voiding or fecal elimination. If blood, urine or feces soil clothing, wash the clothing separately. Manufactured by: The University of Utah DBA Cyclotron Radiochemistry Lab Hunstman Cancer Institute 2000 Circle of Hope, UT 84112 Distributed by: The University of Utah DBA Cyclotron Radiochemistry Lab Hunstman Cancer Institute 2000 Circle of Hope, UT 84112"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Sodium Fluoride F18 Injection emits radiation and must be handled with appropriate safety measures (2.1). Administer 300-450 MBq (8–12 mCi) as an intravenous injection in adults (2.4). Administer approximately 2.1 MBq/kg in children with a minimum of 19 MBq (0.5 mCi) and a maximum of 148 MBq (4 mCi) as an intravenous injection (2.5). Imaging can begin 1–2 hours after administration; optimally at one hour post administration (2.7). Encourage patients to void immediately prior to imaging the lumbar spine and bony pelvis (2.7). 2.1 Radiation Safety - Drug Handling Wear waterproof gloves and effective shielding when handling Sodium Fluoride F 18 Injection. Use appropriate safety measures, including shielding, consistent with proper patient management to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel, and other persons. Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. Use aseptic technique to maintain sterility during all operations involved in the manipulation and administration of Sodium Fluoride F 18 Injection. The dose of Sodium Fluoride F 18 Injection should be minimized consistent with the objectives of the procedure, and the nature of the radiation detection devices employed. The final dose for the patient should be calculated using proper decay factors from the time of End of Synthesis (EOS), and measured by a suitable radioactivity calibration system before administration [see Description (11.2)]. 2.2 Radiation Safety - Patient Preparation To minimize the radiation-absorbed dose to the bladder, encourage adequate hydration. Encourage the patient to ingest at least 500 mL of fluid immediately prior and subsequent to the administration of Sodium Fluoride F 18 Injection. Encourage the patient to void one-half hour after administration of Sodium Fluoride F 18 Injection and as frequently thereafter as possible for the next 12 hours. 2.3 Drug Preparation and Administration Calculate the necessary volume to administer based on calibration time and dose. Inspect Sodium Fluoride F 18 Injection visually for particulate matter and discoloration before administration, whenever solution and container permit. Do not administer Sodium Fluoride F 18 Injection containing particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations. Aseptically withdraw Sodium Fluoride F 18 Injection from its container. 2.4 Recommended Dose for Adults Administer 300–450 MBq (8–12 mCi) as an intravenous injection. 2.5 Recommended Dose for Pediatric Patients In reported clinical experience in approximately 100 children, weight based doses (2.1 MBq/kg) ranging from 19 MBq–148 MBq (0.5 mCi–4 mCi) were used. 2.6 Radiation Dosimetry The age/weight- based estimated absorbed radiation doses (mGy/MBq) from intravenous injection of Sodium Fluoride F 18 Injection are shown in Table 1. These estimates were calculated based on human data and using the data published by the Nuclear Regulatory Commission [1] and the International Commission on Radiological Protection for Sodium Fluoride Injection [2]. The bone, bone marrow and urinary bladder are considered target and critical organs. Table 1: Estimated Absorbed Radiation Doses after Intravenous Administration of Sodium Fluoride F 18 Injection Organ Estimated Radiation Dose mGy/MBq Adult 70 kg [1] 15 year 56.8 kg [2] 10 year 33.2 kg [2] 5 year 19.8 kg [2] 1 year 9.7 kg [2] Adrenals 0.0062 0.012 0.018 0.028 0.052 Brain 0.0056 N/A N/A N/A N/A Bone surfaces 0.060 0.050 0.079 0.13 0.30 Breasts 0.0028 0.0061 0.0097 0.015 0.030 GI Gallbladder wall 0.0044 N/A N/A N/A N/A Stomach wall 0.0038 0.008 0.013 0.019 0.036 Small intestine 0.0066 0.012 0.018 0.028 0.052 Upper large intestine wall 0.0058 0.010 0.016 0.026 0.046 Lower large intestine wall 0.012 0.016 0.025 0.037 0.063 Heart wall 0.0039 N/A N/A N/A N/A Kidneys 0.019 0.025 0.036 0.053 0.097 Liver 0.0040 0.0084 0.013 0.021 0.039 Lungs 0.0041 0.0084 0.013 0.020 0.039 Muscle 0.0060 N/A N/A N/A N/A Ovaries 0.011 0.016 0.023 0.036 0.063 Pancreas 0.0048 0.0096 0.015 0.023 0.044 Red marrow 0.028 0.053 0.088 0.18 0.38 Skin 0.0040 N/A N/A N/A N/A Spleen 0.0042 0.0088 0.014 0.021 0.041 Testes 0.0078 0.013 0.021 0.033 0.062 Thymus 0.0035 N/A N/A N/A N/A Thyroid 0.0044 0.0084 0.013 0.020 0.036 Urinary bladder wall 0.25 0.27 0.4 0.61 1.1 Uterus 0.019 0.023 0.037 0.057 0.099 Other tissue N/A 0.010 0.015 0.024 0.044 Effective Dose Equivalent mSv/MBq 0.027 0.034 0.052 0.086 0.17 [1] Data from Nuclear Regulatory Commission Report, Radiation Dose Estimates for Radiopharmaceuticals, NUREG/CR-6345, page 10, 1996. [2] Data from ICRP publication 53, Radiation Dose to Patients from Radiopharmaceuticals , Ann ICRP, Volume 18, pages 15 and 74, 1987 2.7 Imaging Guidelines Imaging of Sodium Fluoride F 18 Injection can begin 1–2 hours after administration; optimally at 1 hour post administration. Encourage the patient to void immediately prior to imaging the fluoride F18 radioactivity in the lumbar spine or bony pelvis."],"spl_product_data_elements":["Sodium Fluoride F 18 Sodium Fluoride F 18 SODIUM CHLORIDE SODIUM FLUORIDE F-18 FLUORIDE ION F-18"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Multiple-dose vial containing 370–7.400 MBq/mL (10–200 mCi/mL) at EOS reference time of no-carrier-added sodium fluoride F18 in aqueous 0.9% sodium chloride solution. Sodium Fluoride F 18 Injection is a clear, colorless, sterile, pyrogen-free and preservative-free solution for intravenous administration. Multiple-dose vial containing 370–7,400 MBq/mL (10–200 mCi/mL) of no-carrier-added sodium fluoride F18 at the end of synthesis (EOS) reference time in aqueous 0.9% sodium chloride solution (3). Sodium Fluoride F 18 Injection is a clear, colorless, sterile, pyrogen-free and preservative-free solution for intravenous administration."],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS Pregnancy: No human or animal data. Any radiopharmaceutical, including Sodium Fluoride F18 injection, may cause fetal harm. Use only if clearly needed (8.1) Nursing: A decision should be made whether to interrupt nursing after Sodium Fluoride F 18 Injection administration or not to administer Sodium Fluoride F 18 Injection taking into consideration the importance of the drug to the mother. (8.3) Pediatrics: Children are more sensitive to radiation and may be at higher risk of cancer from Sodium Fluoride F18 injection (8.4). 8.1 Pregnancy Pregnancy Category C Any radiopharmaceutical including Sodium Fluoride F 18 Injection has a potential to cause fetal harm. The likelihood of fetal harm depends on the stage of fetal development, and the radionuclide dose. Animal reproductive and developmental toxicity studies have not been conducted with Sodium Fluoride F 18 Injection. Prior to the administration of Sodium Fluoride F 18 Injection to women of childbearing potential, assess for presence of pregnancy. Sodium Fluoride F 18 Injection should be given to a pregnant woman only if clearly needed. 8.3 Nursing Mothers It is not known whether Sodium Fluoride F 18 Injection is excreted into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of Sodium Fluoride F 18 Injection or not to administer Sodium Fluoride F 18 Injection, taking into account the importance of the drug to the mother. The body of scientific information related to radioactivity decay, drug tissue distribution and drug elimination shows that less than 0.01% of the radioactivity administered remains in the body after 24 hours (10 half-lives). To minimize the risks to a nursing infant, interrupt nursing for at least 24 hours. 8.4 Pediatric Use In reported clinical experience in approximately 100 children, weight based doses (2.1 MBq/kg) ranging from 19 MBq–148 MBq (0.5 mCi - 4 mCi) were used. Sodium Fluoride F18 was shown to localize to areas of bone turnover including rapidly growing epiphyses in developing long bones. Children are more sensitive to radiation and may be at higher risk of cancer from Sodium Fluoride F18 injection."],"dosage_and_administration_table":["<table ID=\"ic549f6f9-7728-4574-8bb6-8894225139ea\"><caption>Table 1: Estimated Absorbed Radiation Doses after Intravenous Administration of Sodium Fluoride F 18 Injection</caption><col width=\"43\"/><col width=\"133\"/><col width=\"86\"/><col width=\"86\"/><col width=\"86\"/><col width=\"86\"/><col width=\"86\"/><tbody><tr><td colspan=\"2\" styleCode=\"Toprule Lrule Rrule \">Organ</td><td colspan=\"5\" align=\"center\" styleCode=\"Toprule Lrule Rrule \">Estimated Radiation Dose mGy/MBq</td></tr><tr><td colspan=\"2\" styleCode=\"Toprule Lrule Rrule \"/><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">Adult  70 kg [1] </td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">15 year  56.8 kg [2] </td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">10 year  33.2 kg [2] </td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">5 year  19.8 kg [2] </td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">1 year  9.7 kg [2] </td></tr><tr><td colspan=\"2\" styleCode=\"Toprule Lrule Rrule \">Adrenals</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0062</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.012</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.018</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.028</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.052</td></tr><tr><td colspan=\"2\" styleCode=\"Toprule Lrule Rrule \">Brain</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0056</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td></tr><tr><td colspan=\"2\" styleCode=\"Toprule Lrule Rrule \">Bone  surfaces </td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.060</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.050</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.079</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.13</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.30</td></tr><tr><td colspan=\"2\" styleCode=\"Toprule Lrule Rrule \">Breasts</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0028</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0061</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0097</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.015</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.030</td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">GI</td><td styleCode=\"Toprule Lrule Rrule \">Gallbladder wall</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0044</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td></tr><tr><td styleCode=\"Lrule Rrule \"/><td styleCode=\"Toprule Lrule Rrule \">Stomach wall</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0038</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.008</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.013</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.019</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.036</td></tr><tr><td styleCode=\"Lrule Rrule \"/><td styleCode=\"Toprule Lrule Rrule \">Small intestine</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0066</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.012</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.018</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.028</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.052</td></tr><tr><td styleCode=\"Lrule Rrule \"/><td styleCode=\"Toprule Lrule Rrule \">Upper large intestine wall</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0058</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.010</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.016</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.026</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.046</td></tr><tr><td styleCode=\"Lrule Rrule \"/><td styleCode=\"Toprule Lrule Rrule \">Lower large intestine wall</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.012</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.016</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.025</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.037</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.063</td></tr><tr><td colspan=\"2\" styleCode=\"Toprule Lrule Rrule \">Heart wall</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0039</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td></tr><tr><td colspan=\"2\" styleCode=\"Toprule Lrule Rrule \">Kidneys</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.019</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.025</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.036</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.053</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.097</td></tr><tr><td colspan=\"2\" styleCode=\"Toprule Lrule Rrule \">Liver</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0040</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0084</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.013</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.021</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.039</td></tr><tr><td colspan=\"2\" styleCode=\"Toprule Lrule Rrule \">Lungs</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0041</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0084</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.013</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.020</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.039</td></tr><tr><td colspan=\"2\" styleCode=\"Toprule Lrule Rrule \">Muscle</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0060</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td></tr><tr><td colspan=\"2\" styleCode=\"Toprule Lrule Rrule \">Ovaries</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.011</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.016</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.023</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.036</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.063</td></tr><tr><td colspan=\"2\" styleCode=\"Toprule Lrule Rrule \">Pancreas</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0048</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0096</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.015</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.023</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.044</td></tr><tr><td colspan=\"2\" styleCode=\"Toprule Lrule Rrule \">Red marrow</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.028</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.053</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.088</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.18</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.38</td></tr><tr><td colspan=\"2\" styleCode=\"Toprule Lrule Rrule \">Skin</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0040</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td></tr><tr><td colspan=\"2\" styleCode=\"Toprule Lrule Rrule \">Spleen</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0042</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0088</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.014</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.021</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.041</td></tr><tr><td colspan=\"2\" styleCode=\"Toprule Lrule Rrule \">Testes</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0078</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.013</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.021</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.033</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.062</td></tr><tr><td colspan=\"2\" styleCode=\"Toprule Lrule Rrule \">Thymus</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0035</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td></tr><tr><td colspan=\"2\" styleCode=\"Toprule Lrule Rrule \">Thyroid</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0044</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.0084</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.013</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.020</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.036</td></tr><tr><td colspan=\"2\" styleCode=\"Toprule Lrule Rrule \">Urinary bladder wall</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.25</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.27</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.4</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.61</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">1.1</td></tr><tr><td colspan=\"2\" styleCode=\"Toprule Lrule Rrule \">Uterus</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.019</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.023</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.037</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.057</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.099</td></tr><tr><td colspan=\"2\" styleCode=\"Toprule Lrule Rrule \">Other tissue</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">N/A</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.010</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.015</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.024</td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \">0.044</td></tr><tr><td colspan=\"2\" styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">Effective Dose Equivalent mSv/MBq</content></td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">0.027</content></td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">0.034</content></td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">0.052</content></td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">0.086</content></td><td align=\"center\" styleCode=\"Toprule Lrule Rrule \"><content styleCode=\"bold\">0.17</content></td></tr></tbody></table>"],"package_label_principal_display_panel":["Sodium Fluoride F 18 Injection 10 mL (67939-020-10) Vial Label Outer Packaging - Container Label SodiumFluorideVialLabe SodiumFluorideOuterPackagingLabel"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Studies to assess reproductive toxicity, mutagenesis and carcinogenesis potential of Sodium Fluoride F 18 Injection have not been performed."]},"tags":[{"label":"Active","category":"status"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"171 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"157 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"156 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"154 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"153 reports"},{"date":"","signal":"NASOPHARYNGITIS","source":"FDA FAERS","actionTaken":"151 reports"},{"date":"","signal":"WEIGHT INCREASED","source":"FDA FAERS","actionTaken":"150 reports"},{"date":"","signal":"TYPE 2 DIABETES MELLITUS","source":"FDA FAERS","actionTaken":"146 reports"},{"date":"","signal":"PERIPHERAL SWELLING","source":"FDA FAERS","actionTaken":"141 reports"},{"date":"","signal":"URTICARIA","source":"FDA FAERS","actionTaken":"141 reports"}],"commonSideEffects":[]},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=SODIUM FLUORIDE F 18","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:06:45.691087+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada 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warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:06:43.976753+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T01:06:54.106493+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200744/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:06:53.262094+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA204497","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:06:43.976758+00:00"}},"offLabel":[],"timeline":[],"ecosystem":[],"mechanism":{"explanation":"Imagine your body as a city with different neighborhoods. Sodium Fluoride F 18 is like a special kind of streetlight that shines brightly in certain neighborhoods, allowing doctors to see what's happening there. This helps doctors diagnose and monitor diseases.","oneSentence":"Sodium Fluoride F 18 is a radioactive compound that accumulates in specific tissues, allowing for imaging of certain bodily functions.","technicalDetail":"Sodium Fluoride F 18 is a positron-emitting radiopharmaceutical that accumulates in areas of high bone turnover, allowing for imaging of bone metabolism and disease."},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=SODIUM%20FLUORIDE%20F%2018","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=SODIUM FLUORIDE F 18","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T15:38:52.080867","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:06:56.971309+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[],"genericName":"sodium fluoride f 18","drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04981509","phase":"PHASE2","title":"Testing of Bevacizumab, Erlotinib, and Atezolizumab in Combination for Advanced-Stage Kidney Cancer","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2022-06-10","conditions":["Hereditary Leiomyomatosis and Renal Cell Carcinoma","Papillary Renal Cell Carcinoma","Renal Cell Carcinoma","Sporadic Papillary Renal Cell Carcinoma","Stage III Renal Cell Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8"],"enrollment":65,"completionDate":"2027-12-31"},{"nctId":"NCT03120624","phase":"PHASE1","title":"VSV-hIFNbeta-NIS With or Without Ruxolitinib Phosphate in Treating Stage IV or Recurrent Endometrial Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Mayo Clinic","startDate":"2017-09-15","conditions":["Metastatic Endometrial Carcinoma","Recurrent Endometrial Adenocarcinoma","Recurrent Endometrial Carcinoma","Recurrent Endometrial Clear Cell Adenocarcinoma","Recurrent Endometrial Endometrioid Adenocarcinoma","Recurrent Endometrial Mixed Cell Adenocarcinoma","Recurrent Endometrial Serous Adenocarcinoma","Recurrent Endometrial Undifferentiated Carcinoma","Recurrent Uterine Corpus Carcinosarcoma","Stage IV Uterine Corpus Cancer AJCC v7"],"enrollment":34,"completionDate":"2028-01-01"},{"nctId":"NCT06373497","phase":"EARLY_PHASE1","title":"Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography","status":"RECRUITING","sponsor":"Katelyn Atkins","startDate":"2025-06-19","conditions":["Oligometastatic Disease"],"enrollment":10,"completionDate":"2026-10"},{"nctId":"NCT06914999","phase":"EARLY_PHASE1","title":"Comparing an Investigational Scan (F-18 NaF PET/CT) to Standard of Care Imaging (F-18 FDG PET/CT) for Evaluating Vascular Complications in Patients Receiving Radiation Therapy for Head and Neck Cancer","status":"RECRUITING","sponsor":"Emory University","startDate":"2024-12-03","conditions":["Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Head and Neck Squamous Cell Carcinoma","Hypopharyngeal Squamous Cell Carcinoma","Laryngeal Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Stage III Hypopharyngeal Carcinoma AJCC v8","Stage III Laryngeal Cancer AJCC v8","Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVA Hypopharyngeal Carcinoma AJCC v8","Stage IVA Laryngeal Cancer AJCC v8","Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IVB Hypopharyngeal Carcinoma AJCC v8","Stage IVB Laryngeal Cancer AJCC v8","Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8"],"enrollment":20,"completionDate":"2027-08-31"},{"nctId":"NCT07068204","phase":"NA","title":"Comparative Study of Caries-Preventive Effects: 2% Calcium Hypophosphite Toothpaste vs. Sodium Fluoride Toothpaste (1450ppm F)","status":"NOT_YET_RECRUITING","sponsor":"Dr. Joachim Enax","startDate":"2025-09","conditions":["Caries, Dental","Calcium Hypophosphite","Fluoridation"],"enrollment":164,"completionDate":"2028-01"},{"nctId":"NCT03095313","phase":"PHASE2","title":"18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes","status":"COMPLETED","sponsor":"Cedars-Sinai Medical Center","startDate":"2017-07-23","conditions":["Aortic Stenosis"],"enrollment":20,"completionDate":"2024-02-16"},{"nctId":"NCT04756557","phase":"NA","title":"Caries-preventing Effect of a Hydroxyapatite-toothpaste in Adults","status":"COMPLETED","sponsor":"Poznan University of Medical Sciences","startDate":"2021-01-01","conditions":["Dental Caries","Hydroxyapatite","Tooth Decay","Dentin, Carious","Enamel Caries"],"enrollment":192,"completionDate":"2023-01-09"},{"nctId":"NCT01967862","phase":"NA","title":"Fluorine F 18 Sodium Fluoride PET/CT and Whole Body and Axial MRI in Finding Metastases in Patients With Recurrent Prostate Cancer","status":"COMPLETED","sponsor":"City of Hope Medical Center","startDate":"2013-12","conditions":["Recurrent Prostate Cancer"],"enrollment":54,"completionDate":"2018-09-17"},{"nctId":"NCT01816048","phase":"PHASE2","title":"NaF Positron Emission Tomography/Computed Tomography (PET/CT)Imaging to Assess Treatment Responsiveness to TAK-700 in Patients With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastasis","status":"TERMINATED","sponsor":"University of Wisconsin, Madison","startDate":"2013-05","conditions":["Prostatic Neoplasms","Prostate Cancer"],"enrollment":8,"completionDate":"2016-11"},{"nctId":"NCT00575393","phase":"PHASE1","title":"Gold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell Lung 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Resistant Metastatic Prostate Cancer","status":"WITHDRAWN","sponsor":"University of Washington","startDate":"2015-12","conditions":["Hormone-resistant Prostate Cancer","Recurrent Prostate Cancer","Stage IV Prostate Cancer"],"enrollment":0,"completionDate":""},{"nctId":"NCT00936975","phase":"PHASE2","title":"Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in Patients With Prostate Cancer and Bone Metastases","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2009-09","conditions":["Hormone-Resistant Prostate Cancer","Metastatic Malignant Neoplasm in the Bone","Recurrent Prostate Carcinoma","Stage IV Prostate Cancer"],"enrollment":18,"completionDate":"2014-12"},{"nctId":"NCT01665248","phase":"NA","title":"Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina","status":"TERMINATED","sponsor":"CHEOL WHAN LEE, MD, 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