Gallium Ga 68 dotatate

(NETSPOT®)

NETSPOT®

Drug updated on 9/5/2024

Dosage FormInjection (intravenous; up to 218 MBq/mL [5.89 mCi/mL])
Drug ClassRadioactive diagnostic agents
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • For use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.

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Summary
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  • NETSPOT (gallium Ga 68 dotatate) is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
  • This summary is based on the review of one systematic review/meta-analysis. [1]
  • True Positivity Rates in Neuroendocrine Tumor Detection: ^64Cu-DOTATATE showed the highest true positivity rate at 82.4%, followed by ^68Ga-DOTATATE/TOC at 78.4%. These PET tracers outperformed the SPECT tracers, ^111In-DTPA-Octreotide (63.7%) and ^99mTc-EDDA/HYNIC-TOC (58.5%), indicating superior effectiveness in identifying neuroendocrine tumors.
  • Comparison of PET vs. SPECT Tracers: The PET tracers (^64Cu-DOTATATE and ^68Ga-DOTATATE/TOC) demonstrated significantly higher true positivity rates compared to the SPECT tracers (^111In-DTPA-Octreotide and ^99mTc-EDDA/HYNIC-TOC), highlighting the enhanced accuracy of PET imaging in detecting neuroendocrine tumors.
  • Population Considerations: The studies included both adult and pediatric patients with neuroendocrine tumors, but the studies did not specify differences in effectiveness among different population subgroups.
  • Safety Information: There is no safety information available in the reviewed studies regarding the radiolabeled peptides (^111In-DTPA-Octreotide, ^99mTc-EDDA/HYNIC-TOC, ^68Ga-DOTATATE/TOC, ^64Cu-DOTATATE).
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
NETSPOT (gallium Ga 68 dotatate) Prescribing Information.2023Advanced Accelerator Applications USA, Inc., Millburn, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines