Last reviewed · How we verify
NCT02103634
NaF PET/MRI Evaluation for Bone Metastases in Breast Cancer
trial testing NaF PET/MRI in Malignant Neoplasm of Breast TNM Staging Distant Metastasis (M) in 29 participants. Completed in 21 December 2018.
21 December 2018
Quick facts
| Lead sponsor | Case Comprehensive Cancer Center |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 29 |
| Start date | 1 March 2014 |
| Primary completion | 21 December 2018 |
| Estimated completion | 21 December 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- NaF PET/MRI
- NaF PET/CT
- FDG PET/CT
Conditions studied
- Malignant Neoplasm of Breast TNM Staging Distant Metastasis (M) — all drugs for Malignant Neoplasm of Breast TNM Staging Distant Metastasis (M) →
- Untreated Bone Metastases — all drugs for Untreated Bone Metastases →
Sponsor
Case Comprehensive Cancer Center — full company profile →
Who can join
18 and older, any sex, with Malignant Neoplasm of Breast TNM Staging Distant Metastasis (M) or Untreated Bone Metastases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will look at two new technologies being developed for measuring cancer in bones. One of these technologies is a substance called Sodium Fluoride (NaF). Fluoride is a normal body substance. The amount that patients will receive has been shown to be very safe. One study of over 400 patients showed no adverse reactions after receiving the recommended dosage. NaF (known as a radiotracer) is taken up into the bones under a normal process and researchers can measure the amount within patient's bones through an imaging system called a Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI). This system combines aspects of both a PET study as part of the regular standard of care and an MRI study. The belief is that the combination of these two studies will be better than either study alone.People who have enrolled in this study will receive their clinically requested PET/CT scan as part of their normal diagnostic care and will follow all the said recommendations for this study such as not being pregnant, having fasted overnight, etc. Subjects will return within 7 days for a 10 mCi NaF PET/MRI study. The patients' imaging time will be up to 120 minutes depending on the MRI sequences acquired. Imaging for the PET portion of the study will take approximately 20-30 minutes with the rest of the time devoted to MRI sequences.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02103634
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Case Comprehensive Cancer Center trials
Trials by the same sponsor.
- NCT06811454 — Mindfulness-based Intervention for Depressive Symptoms Sent Via Text (MINDSET) · NA · not yet recruiting
- NCT07167056 — Artificial Intelligence-Powered Support For Quality Of Life Improvement In Participants With Cancer · NA · recruiting
- NCT07084779 — Investigation of Impact of AI on Prostate Cancer Workflow · NA · recruiting
- NCT06904482 — Co-Transplant of an Unmodified Haplo-Identical Graft With Cord Blood · Phase 2 · recruiting
- NCT07044362 — Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02103634 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Case Comprehensive Cancer Center
- Last refreshed: 29 July 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02103634.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing