Gallium (68Ga) Edotreotide PET/CT for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors

Hengrui Medicine

Status and phase: Enrolling; Phase 3

Conditions: Advanced Gastroenteropancreatic Neuroendocrine Tumor

Treatments: Drug: 68Ga-DOTATOC

Study type: Interventional

Funder types: Industry

Identifiers

NCT06091748

HRFS-Q-2010-301

Details and patient eligibility

About

This is a single-arm imaging study using DOTATOC peptide, labelled with the Gallium (68Ga) tracer.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

66 participants in 1 patient group

PET/CT imaging with 68Ga-DOTATOC

Experimental group

Treatment:

Drug: 68Ga-DOTATOC