Drug updated on 12/11/2024
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
Summary
- This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-2]
- Predictive Value for Progression-Free Survival (PFS): In patients with neuroendocrine neoplasms (NENs), 64Cu-DOTATATE uptake measured by maximum standardized uptake value (SUVmax) was prognostic for PFS, with an SUVmax cutoff of 43.3 associated with a Hazard Ratio (HR) of 0.56 (95% confidence interval (CI): 0.38–0.84). The accuracy for predicting PFS at 24 months was moderate at 57%.
- Diagnostic Performance: In patients with somatostatin receptor (SSTR)-expressing neuroendocrine tumors (NETs), 64Cu-DOTATATE Positron Emission Tomography/Computed Tomography (PET/CT) demonstrated high sensitivity (90.9%) and specificity (96.6%), which increased to 100.0% and 96.8%, respectively, after correcting for an initial standard-of-truth misread. The method reliably distinguished between localized and metastatic disease.
- No adverse events were related to the administration of 64Cu-DOTATATE, and no serious adverse events were observed during the study period (injection through 48 hours post-injection).
- No significant safety concerns or adverse effects were reported in the reviewed studies.
- The reviewed studies focused on patients with NENs and SSTR-expressing NETs, highlighting the prognostic value of 64Cu-DOTATATE uptake for PFS in NENs without demonstrating Overall Survival (OS) benefits, and its high diagnostic sensitivity and specificity for SSTR-expressing NETs, with no significant subgroup differences noted.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Detectnet (copper Cu 64 dotatate) Prescribing Information. | 2021 | Curium US LLC, Maryland Heights, MO |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
(64)Cu-DOTATATE PET/CT and Prediction of Overall and Progression-Free Survival in Patients with Neuroendocrine Neoplasms | 2020 | Journal Of Nuclear Medicine : Official Publication, Society Of Nuclear Medicine |
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 | 2020 | Journal Of Nuclear Medicine : Official Publication, Society 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 |