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Trial Title:
Gallium (68Ga) Edotreotide PET/CT for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors
NCT ID:
NCT06091748
Condition:
Advanced Gastroenteropancreatic Neuroendocrine Tumor
Conditions: Official terms:
Neuroendocrine Tumors
Edotreotide
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68Ga-DOTATOC
Description:
Detection of somatostatin positive lesions in GEP-NETs
Arm group label:
PET/CT imaging with 68Ga-DOTATOC
Summary:
This is a single-arm imaging study using DOTATOC peptide, labelled with the Gallium
(68Ga) tracer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Able and willing to provide a written informed consent;
2. 18~75 years old,male or female；
3. ECOG performance status 0 or 1;
4. Confirmed or suspicion of GEP-NET.
Exclusion Criteria:
1. Unable to lie flat for the entire imaging duration (e.g. persistent cough,
claustrophobia, severe arthritis, etc.), unable to enter the PET/CT device;
2. Individuals planning to be pregnant, and lactating women;
3. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
November 1, 2023
Completion date:
November 1, 2024
Lead sponsor:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Jiangsu HengRui Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06091748
