Overview
Copper Cu 64 dotatate is a newly approved Cu labeled somatostatin analog and has several advantages over Ga-labeled somatostatin analogs for positron emission tomography (PET). Copper Cu 64 dotatate has a longer half-life and can be produced once a day as opposed to several times a day, and lower positron energy lending to improved spatial resolution. Further studies should be performed to compare the two tracers. Further, PET using Copper Cu 64 dotatate has been found to perform better than the current gold standard of single-photon emission computed tomography (SPECT) using 111In-DTPA-octreotide. In a head-to-head trial, the former tracer detected twice as many lesions as the latter.
Background
Copper Cu 64 dotatate is a newly approved Cu labeled somatostatin analog and has several advantages over Ga-labeled somatostatin analogs for positron emission tomography (PET). Copper Cu 64 dotatate has a longer half-life and can be produced once a day as opposed to several times a day, and lower positron energy lending to improved spatial resolution. Further studies should be performed to compare the two tracers. Further, PET using Copper Cu 64 dotatate has been found to perform better than the current gold standard of single-photon emission computed tomography (SPECT) using 111In-DTPA-octreotide. In a head-to-head trial, the former tracer detected twice as many lesions as the latter.
Indication
Copper Cu 64 Dotatate is a radiopharmaceutical used with positron emission tomography(PET) to locate somatostatin receptor-positive neuroendocrine tumors.
Associated Conditions
- Somatostatin Receptor Positive Neuroendocrine Tumours
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/11/08 | Phase 1 | Recruiting | |||
2023/02/02 | Phase 2 | ENROLLING_BY_INVITATION | |||
2018/09/17 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| CURIUM US LLC | 69945-064 | INTRAVENOUS | 1.0 mCi in 1 mL | 9/14/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||