Gallium-68 DOTATOC PET/CT imaging for advanced gastroenteropancreatic neuroendocrine tumors
An Open-label, Single Arm Clinical Trial of Gallium (68Ga) Edotreotide PET-CT Scan for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors
We will test whether a Gallium-68 DOTATOC PET/CT scan can better detect tumors in adults with advanced gastroenteropancreatic neuroendocrine tumors.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06091748 on ClinicalTrials.gov |
What this trial studies
This is a single-arm, phase 3 imaging study in which participants receive DOTATOC labeled with the Gallium-68 tracer followed by PET/CT scanning to visualize neuroendocrine tumors. Eligible adults (18–75 years) must have confirmed or suspected gastroenteropancreatic neuroendocrine tumors and good functional status (ECOG 0–1). The study is conducted at Beijing Cancer Hospital and sponsored by Jiangsu HengRui Medicine Co., Ltd. Imaging results will be used to characterize lesion detection and distribution compared with current diagnostic expectations.
Who should consider this trial
Good fit: Adults aged 18–75 with confirmed or suspected advanced gastroenteropancreatic neuroendocrine tumors and ECOG performance status 0–1 who can undergo PET/CT scanning are suitable candidates.
Not a fit: People who cannot lie flat for the scan, are pregnant or breastfeeding, or have active infections/fever are unlikely to be eligible or benefit from participation.
Why it matters
Potential benefit: If successful, this imaging approach could help doctors see and locate GEP-NETs more clearly and improve diagnosis and treatment planning.
How similar studies have performed: Radiolabeled somatostatin analog PET/CT (including Ga-68 DOTATOC/DOTATATE) has already shown improved lesion detection in multiple prior studies, so this study largely aims to confirm those findings in this setting.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Pan Huang
- Email: pan.huang.ph18@hengrui.com
- Phone: +0518-82342973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.