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Drug updated on 5/17/2024
Dosage Form | Injection (intravenous; 148 MBq (4 mCi), [37 MBq 1 mCi /mL]) |
Drug Class | Radioactive diagnostic agents |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuro-endocrine tumors (NETs) in adults.
Summary
- Copper Cu 64 dotatate injection (Detectnet) is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor-positive neuro-endocrine tumors (NETs) in adults.
- Two studies from randomized controlled trials were reviewed to gather information about Detectnet's safety and effectiveness.
- Both studies underline the safety of Detectnet, reporting no direct mention of adverse effects related to its usage. The second study explicitly states that no adverse events were related to Detectnet, indicating a high safety profile for diagnostic use in patients with somatostatin-receptor-positive NETs.
- In terms of effectiveness, one study suggests Detectnet's effective imaging capability even beyond its primary indicated use, while the other confirms its effectiveness by reporting high diagnostic performance metrics including sensitivity and specificity rates as high as 100% and 96.8%, respectively.
- The first study focuses on patients with type 2 diabetes, suggesting potential broader application possibilities for Detectnet beyond the immediate indication, whereas the second provides detailed information concerning diagnostic quality specifically in patients with somatostatin-receptor-positive NETs, highlighting its specificity and sensitivity within this population group.
- Compared to other imaging agents mentioned in these studies, both position copper Cu 64 dotatate injection (Detectnet) favorably due to the absence of reported adverse events or serious conditions, along with exhibiting higher resolution images at an identified optimal dose, making it a highly effective tool over possibly lower-resolution or less-specific imaging alternatives.
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. | Data not availableSubjects F: null% M: null% | 2020 | The Journal of Nuclear Medicine |
Sex Distribution:
F:17%
M:83%
30Subjects
Year:
2021
Source:Frontiers in Endocrinology
Sex Distribution:
![No Data](/img/Nodata_Icon.png)
Year:
2020
Source:The Journal of Nuclear Medicine
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Gastroenteropancreatic neuroendocrine neoplasms: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. | 2020 | Annals of Oncology |