Advanced Gastroenteropancreatic Neuroendocrine Tumor
Conditions
Brief summary
This is a single-arm imaging study using DOTATOC peptide, labelled with the Gallium (68Ga) tracer.
Interventions
DRUG68Ga-DOTATOC
Detection of somatostatin positive lesions in GEP-NETs
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Incidence and severity of AE and SAE | up to 1 year follow-up |
Countries
China
Outcome results
None listed