Skip to main content
OpenTrials
Completed

NCT Number: NCT06091748

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Gastroenteropancreatic Neuroendocrine Tumor

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

68Ga-DOTATOC

Drug

Detection of somatostatin positive lesions in GEP-NETs

Primary outcomes

  1. Sensitivity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET

    Time frame: 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

  2. Specificity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET

    Time frame: 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 outcomes

  1. Incidence and severity of AE and SAE

    Time frame: up to 1 year follow-up

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

An Open-label, Single Arm Clinical Trial of Gallium (68Ga) Edotreotide PET-CT Scan for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 19, 2023
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.