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68Ga-DOTATOC PET-CT Imaging in GEP-NETs
NCT06091748Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2024
- Primary completion
- Nov 2025
- Countries
- 1
- Sponsor
- Hengrui
- Modality
- Peptides
- Conditions
- gastroenteropancreatic neuroendocrine tumor (GEP-NET)
01
Overview
Phase 3, open-label, single-arm trial of gallium Ga 68-edotreotide in gastroenteropancreatic neuroendocrine tumor (GEP-NET), sponsored by Hengrui. Primary endpoints: Sensitivity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET at 12 months and Specificity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET at 12 months. Started Feb 2024; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
PET/CT imaging with 68Ga-DOTATOC
Patients receive 68Ga-DOTATOC for the detection of somatostatin positive lesions in GEP-NETs via PET/CT scan.
03
Who it enrols
Adults aged 18-75 with confirmed or suspected GEP-NET and ECOG 0-1, excluding pregnant/lactating women, those unable to lie flat for PET/CT, and those with active infections or unexplained fever.
04
Endpoints
Primary
Sensitivity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET
Specificity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET
Secondary
Incidence and severity of Adverse Events and Serious Adverse Events
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