Gallium (68Ga) Edotreotide PET/CT for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors
Phase 3
Not yet recruiting
- Conditions
- Advanced Gastroenteropancreatic Neuroendocrine Tumor
- Interventions
- Registration Number
- NCT06091748
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
This is a single-arm imaging study using DOTATOC peptide, labelled with the Gallium (68Ga) tracer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
- Able and willing to provide a written informed consent;
- 18~75 years old,male or female；
- ECOG performance status 0 or 1;
- Confirmed or suspicion of GEP-NET.
Exclusion Criteria
- Unable to lie flat for the entire imaging duration (e.g. persistent cough, claustrophobia, severe arthritis, etc.), unable to enter the PET/CT device;
- Individuals planning to be pregnant, and lactating women;
- Individuals with concurrent active infections or with unexplained fever >38.5°C for more than 1 hour during the screening period or prior to administration of investigational medication.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PET/CT imaging with 68Ga-DOTATOC 68Ga-DOTATOC -
- Primary Outcome Measures
Name Time Method Sensitivity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET 12 months The number of patients with SSTR (+) GEP-NETs disease that was confirmed by imaging using 68Ga-DOTATOC PET/CT and Standard of Truth
Specificity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET 12 months The number of patients who have no SSTR (+) GEP-NETs disease that was confirmed by imaging using 68Ga-DOTATOC PET/CT and Standard of Truth
- Secondary Outcome Measures
Name Time Method Incidence and severity of AE and SAE up to 1 year follow-up