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64Cu-DOTATATE
64Cu-DOTATATE is a radioactive diagnostic imaging agent that binds to somatostatin receptors on neuroendocrine tumor cells, allowing detection via positron emission tomography (PET).
64Cu-DOTATATE is a radioactive diagnostic imaging agent that binds to somatostatin receptors on neuroendocrine tumor cells, allowing detection via positron emission tomography (PET). Used for Imaging of somatostatin receptor-positive neuroendocrine tumors, Detection and staging of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
At a glance
| Generic name | 64Cu-DOTATATE |
|---|---|
| Also known as | NETMEDIX, Detectnet, Copper (64Cu) oxodotreotide |
| Sponsor | Radiomedix, Inc. |
| Drug class | Radiopharmaceutical; PET imaging agent |
| Target | Somatostatin receptor 2 (SSTR2) |
| Modality | Small molecule |
| Therapeutic area | Oncology; Diagnostic Imaging |
| Phase | Phase 3 |
Mechanism of action
64Cu-DOTATATE consists of the radioisotope copper-64 conjugated to DOTATATE, a somatostatin analog that selectively targets somatostatin receptor subtype 2 (SSTR2) expressed on neuroendocrine tumors. The copper-64 emits positrons enabling PET imaging to localize and visualize tumors. This allows clinicians to detect, stage, and monitor neuroendocrine neoplasms with high specificity.
Approved indications
- Imaging of somatostatin receptor-positive neuroendocrine tumors
- Detection and staging of gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
Common side effects
- Radiation exposure (expected from PET imaging)
- Injection site reactions
- Transient hyperglycemia
Key clinical trials
- Using Novel Imaging to More Safely Treat Neuroendocrine Tumors (PHASE1)
- NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. (PHASE1)
- Combination External Radiation and PRRT for Large GI Neuroendocrine Tumors. (PHASE1)
- Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs (PHASE2)
- Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors (PHASE4)
- Clinical Application of Somatostatin Receptor and Norepinephrine Transporter Targeted Imaging for Diagnosis and Staging of Neuroblastoma and Pheochromocytoma/Paraganglioma
- Randomized Interval Assessment Trial of Lu177-Dotatate in Slowly Progressive G1-2 Advanced Midgut Neuroendocrine Tumors (PHASE3)
- 64Cu-DOTATATE PET-CT-skanning and Infective Endocarditis. (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |