Advanced Gastroenteropancreatic Neuroendocrine TumorPhase 3NCT06091748
Gallium (68Ga) Edotreotide PET/CT for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors
A Phase 3 study testing 68Ga-DOTATOC in people with Advanced Gastroenteropancreatic Neuroendocrine Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a single-arm imaging study using DOTATOC peptide, labelled with the Gallium (68Ga) tracer. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Gastroenteropancreatic Neuroendocrine Tumor
- What is being tested?
- 68Ga-DOTATOC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2024to 27 Nov 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single Arm Clinical Trial of Gallium (68Ga) Edotreotide PET-CT Scan for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors
This is a single-arm imaging study using DOTATOC peptide, labelled with the Gallium (68Ga) tracer.
- Being tested
- 68Ga-DOTATOC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTATOCDrug
Detection of somatostatin positive lesions in GEP-NETs
| Study group | Role | What they receive |
|---|---|---|
| PET/CT imaging with 68Ga-DOTATOC | Experimental | Not described Receives: Drug: 68Ga-DOTATOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET
The number of patients with SSTR (+) GEP-NETs disease that was confirmed by imaging using 68Ga-DOTATOC PET/CT and Standard of Truth
Measured: 12 months
Specificity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET
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
Measured: 12 months
Secondary outcomes (1)
Incidence and severity of AE and SAE
Measured: up to 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start22 Feb 2024
- Primary completion27 Nov 2025
- Study completion27 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastroenteropancreatic Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091748
- Sponsor's protocol ID
- HRFS-Q-2010-301
- Status last verified
- Jun 2026
- First submitted
- 16 Oct 2023
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided