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Copper Cu 64 Dotatate
Copper Cu 64 Dotatate is a Radiopharmaceutical; somatostatin receptor agonist imaging agent Small molecule drug developed by Vanderbilt-Ingram Cancer Center. It is currently FDA-approved for PET imaging of somatostatin receptor-positive neuroendocrine tumors.
Copper Cu 64 Dotatate is a radioactive imaging agent that binds to somatostatin receptors on neuroendocrine tumor cells, allowing PET visualization and localization of these tumors.
Copper Cu 64 Dotatate is a radiopharmaceutical used to treat various types of tumors, including neuroendocrine tumors, intestinal neoplasms, pancreatic neoplasms, stomach neoplasms, and neuroectodermal tumors. It is a protein-based modality that targets specific proteins, as indicated by its use in treating conditions such as those listed on ClinicalTrials.gov.
At a glance
| Generic name | Copper Cu 64 Dotatate |
|---|---|
| Sponsor | Vanderbilt-Ingram Cancer Center |
| Drug class | Radiopharmaceutical; somatostatin receptor agonist imaging agent |
| Target | Somatostatin receptor 2 (SSTR2) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Dotatate is a somatostatin analog conjugated to copper-64, a positron-emitting radionuclide. The dotatate peptide binds with high affinity to somatostatin receptor subtype 2 (SSTR2) expressed on neuroendocrine tumors. The copper-64 radiolabel enables positron emission tomography (PET) imaging to detect and localize SSTR2-positive tumors in the body.
Approved indications
- PET imaging of somatostatin receptor-positive neuroendocrine tumors
Common side effects
- Injection site reactions
- Nausea
- Flushing
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Copper Cu 64 Dotatate CI brief — competitive landscape report
- Copper Cu 64 Dotatate updates RSS · CI watch RSS
- Vanderbilt-Ingram Cancer Center portfolio CI
Frequently asked questions about Copper Cu 64 Dotatate
What is Copper Cu 64 Dotatate?
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Related
- Drug class: All Radiopharmaceutical; somatostatin receptor agonist imaging agent drugs
- Target: All drugs targeting Somatostatin receptor 2 (SSTR2)
- Manufacturer: Vanderbilt-Ingram Cancer Center — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for PET imaging of somatostatin receptor-positive neuroendocrine tumors
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing