Copper Cu 64 dotatate

(Detectnet®)

Copper Cu 64 dotatate

Drug updated on 12/11/2024

Dosage FormInjection (intravenous; 148 MBq (4 mCi), [37 MBq 1 mCi /mL])
Drug ClassRadioactive 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

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Summary
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  • 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 TitleYearSource
Detectnet (copper Cu 64 dotatate) Prescribing Information.2021Curium US LLC, Maryland Heights, MO

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines