Drug updated on 9/5/2024
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.
Latest News
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Summary
- Detectnet (copper Cu 64 dotatate injection) is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor-positive neuroendocrine tumors (NETs) in adults.
- This summary is based on the review of two randomized controlled trial(s). [1-2]
- In patients with type 2 diabetes, liraglutide treatment for 26 weeks significantly reduced [64Cu]Cu-DOTATATE uptake values in coronary inflammation, with participant-level SUV_max (p=0.013) and mSUV_max (p=0.004) showing significant reductions. At the coronary-segment level, SUV_max (p=0.001) and mSUV_max (p<0.0001) also showed significant decreases. The placebo group showed no significant change in uptake values.
- In patients with somatostatin receptor (SSTR)-expressing neuroendocrine tumors (NETs), [64Cu]Cu-DOTATATE PET/CT demonstrated high diagnostic performance, with a sensitivity of 90.9% (p=0.0042) and specificity of 96.6% (p<0.0001). After correcting an initial misread, sensitivity increased to 100.0% and specificity to 96.8%, indicating effective detection of localized and metastatic disease.
- The first study on coronary inflammation and atherosclerosis did not report specific safety outcomes or adverse effects related to the use of [64Cu]Cu-DOTATATE.
- In the second study on neuroendocrine tumors (NETs), no adverse events related to [64Cu]Cu-DOTATATE were observed, and there were no serious adverse events reported, indicating a favorable safety profile for this radiopharmaceutical.
- There is no population types or subgroups information available in the reviewed studies.
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 |