Copper Cu 64 dotatate injection

(Detectnet®)

Detectnet®

Drug updated on 9/5/2024

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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  • 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.