Drug updated on 3/28/2024
| Dosage Form | Injection (intravenous; 148 MBq (4 mCi), 37 MBq (1 mCi) per 1 mL) |
| Drug Class | Radioactive diagnostic agents |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For detection of the specific type of tumors called somatostatin receptor positive neuro-endocrine tumors (NETs) in adults.
Summary
- Copper Cu 64 dotatate (Detectnet) is used for the detection of somatostatin receptor positive neuro-endocrine tumors (NETs) in adults.
- Two randomized controlled trials were reviewed to gather information about Detectnet's effectiveness and safety.
- In one trial, Detectnet was utilized as a radioactive tracer in positron emission tomography (PET), targeting activated macrophages in coronary arteries of patients with type 2 diabetes undergoing liraglutide treatment; it showed significant reduction in uptake after 26 weeks of treatment, indicating its potential use for quantifying coronary artery inflammation and atherosclerosis.
- The same study also found that baseline Detectnet uptake values correlated weakly with high-sensitivity c-reactive protein, an inflammatory biomarker, suggesting its possible role as a marker of systemic inflammation.
- Another phase III study demonstrated that at an optimal dose of 148 MBq (4 mCi), Detectnet provided diagnostic-quality PET/CT images with excellent inter- and intrareader reliability; it had sensitivity rates over 90% and specificity rates above 96% for detecting NETs among healthy volunteers and NET-positive patients alike.
- This latter trial reported no adverse events related to the administration of copper Cu-64 DOTATATE within the observed period up to two days post-injection, highlighting its safety profile when used at this dosage level for imaging purposes.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Detectnet (copper Cu 64 dotatate injection) Prescribing Information. | 2021 | Curium US LLC., Maryland Heights, MO |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Effect of 26 Weeks of Liraglutide Treatment on Coronary Artery Inflammation in Type 2 Diabetes Quantified by [64Cu]Cu-DOTATATE PET/CT: Results from the LIRAFLAME Trial. | 30Subjects F: 17% M: 83% | 2021 | Frontiers in endocrinology |
| 64Cu-DOTATATE PET/CT for imaging patients with known or suspected somatostatin receptor–positive neuroendocrine tumors: results of the first U.S. prospective, reader-masked clinical trial. | 75Subjects F: 56% M: 44% | 2020 | The Journal of Nuclear Medicine |
Sex Distribution:
F:17%
M:83%
30Subjects
Year:
2021
Source:Frontiers in endocrinology
Sex Distribution:
F:56%
M:44%
75Subjects
Year:
2020
Source:The Journal of Nuclear Medicine