Clinical trial
An Open-label, Single Arm Clinical Trial of Gallium (68Ga) Edotreotide PET-CT Scan for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors
Name
HRFS-Q-2010-301
Description
This is a single-arm imaging study using DOTATOC peptide, labelled with the Gallium (68Ga) tracer.
Trial arms
Trial start
2023-11-01
Estimated PCD
2024-11-01
Trial end
2024-11-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
68Ga-DOTATOC
Detection of somatostatin positive lesions in GEP-NETs
Arms:
PET/CT imaging with 68Ga-DOTATOC
Size
66
Primary endpoint
Sensitivity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET
12 months
Specificity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET
12 months
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 66, 'type': 'ESTIMATED'}}
Updated at
2023-10-19
1 organization
1 product
1 indication
Organization
Jiangsu HengRui MedicineProduct
68Ga-DOTATOC