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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Arm Clinical Trial of Gallium (68Ga) Edotreotide PET-CT Scan for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT06091748
- Acronym / sponsor ID
- HRFS-Q-2010-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 27 Nov 2025 (actual)
- Study completion
- 27 Nov 2025 (actual)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm imaging study using DOTATOC peptide, labelled with the Gallium (68Ga) tracer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT imaging with 68Ga-DOTATOC | Experimental | Drug: 68Ga-DOTATOC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-DOTATOCDetection of somatostatin positive lesions in GEP-NETs | Drug | PET/CT imaging with 68Ga-DOTATOC |
Primary outcome
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
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
1 secondary outcome
Incidence and severity of AE and SAE
Time frame: up to 1 year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.