InsulinomaNCT07340437
Clinical Study of 18F-Exendin-4 in Insulinoma
An observational study of Insulinoma, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial summary
The goal of this observational study is to evaluate the diagnostic value of ¹⁸F-Exendin-4 PET/CT imaging in renal insulinoma. Participants will undergo clinical evaluation and ¹⁸F-Exendin-4 PET/CT examination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insulinoma
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 31 Dec 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosed or highly suspected insulinoma.
Who may be able to join
- biochemically confirmed hyperinsulinemic hypoglycemia (plasma glucose < 3.0 mmol/L, insulin > 3 μIU/mL, C-peptide > 0.6 ng/mL)
- surgical or biopsy-confirmed insulinoma or non-insulinoma pancreatogenous hypoglycemia syndrome, with definitive clinical diagnosis at discharge and comprehensive evaluation for hypoglycemia etiology during hospitalization.
Who cannot join
- unknown etiology of hypoglycemia at last follow-up
- patients clinically diagnosed with insulinoma but without subsequent surgical intervention or biopsy
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Endocrinology and Department of Nuclear Medicine, Sichuan Provincial People's Hospital, Chengdu, Sichuan 610072
Chengdu
About this study
Official title: Clinical Study of an ¹⁸F-labeled GLP-1R Probe in Insulinoma
The goal of this observational study is to evaluate the diagnostic value of ¹⁸F-Exendin-4 PET/CT imaging in renal insulinoma. Participants will undergo clinical evaluation and ¹⁸F-Exendin-4 PET/CT examination.
Read the detailed description
Early detection, precise diagnosis, and accurate localization are key to the effective management of insulinoma, the most common functional pancreatic neuroendocrine tumor, which is predominantly benign. Histopathological examination remains the diagnostic gold standard, but invasive procedures such as biopsy carry risks of bleeding and hematoma, while rarer complications like infection or pancreatic fistula may also occur. Therefore, there is an urgent clinical need for a highly accurate, non-invasive diagnostic method.
The glucagon-like peptide-1 receptor is overexpressed in insulinomas, making GLP-1R-targeted imaging a major focus in the molecular imaging of this disease. Exendin-4, an analog of GLP-1R agonists, has been shown to specifically bind to GLP-1R when labeled with ⁶⁸Ga, enabling targeted diagnosis of insulinoma. However, compared to ⁶⁸Ga, ¹⁸F offers significant advantages. Although ¹⁸F-labeled exendin-4 has been explored in preclinical studies, its clinical translation has not yet been reported. Therefore, investigating the imaging performance of ¹⁸F-exendin-4 PET/CT in insulinoma is of high clinical relevance.
- Conditions
- Insulinoma
- Medical subject headings
- Insulinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between clinical indicators and PET/CT results
Correlation analysis of clinical biochemical indicators, endoscopic ultrasound, contrast-enhanced CT, contrast-enhanced MRI with ¹⁸F-Exendin-4 PET/CT results.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Feb 2023
- Primary completion31 Oct 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsulinomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Wang, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340437
- Sponsor's protocol ID
- SichuanPPH-Insulinoma
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of an ¹⁸F-labeled GLP-1R Probe in Insulinoma
- ClinicalTrials.gov ID
- NCT07340437
- Acronym / sponsor ID
- SichuanPPH-Insulinoma
- Conditions
- Insulinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 14 Jan 2026 (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.
The goal of this observational study is to evaluate the diagnostic value of ¹⁸F-Exendin-4 PET/CT imaging in renal insulinoma. Participants will undergo clinical evaluation and ¹⁸F-Exendin-4 PET/CT examination.
Detailed description
Early detection, precise diagnosis, and accurate localization are key to the effective management of insulinoma, the most common functional pancreatic neuroendocrine tumor, which is predominantly benign. Histopathological examination remains the diagnostic gold standard, but invasive procedures such as biopsy carry risks of bleeding and hematoma, while rarer complications like infection or pancreatic fistula may also occur. Therefore, there is an urgent clinical need for a highly accurate, non-invasive diagnostic method.
The glucagon-like peptide-1 receptor is overexpressed in insulinomas, making GLP-1R-targeted imaging a major focus in the molecular imaging of this disease. Exendin-4, an analog of GLP-1R agonists, has been shown to specifically bind to GLP-1R when labeled with ⁶⁸Ga, enabling targeted diagnosis of insulinoma. However, compared to ⁶⁸Ga, ¹⁸F offers significant advantages. Although ¹⁸F-labeled exendin-4 has been explored in preclinical studies, its clinical translation has not yet been reported. Therefore, investigating the imaging performance of ¹⁸F-exendin-4 PET/CT in insulinoma is of high clinical relevance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosed or highly suspected insulinoma.
Key inclusion criteria (2 listed)
- biochemically confirmed hyperinsulinemic hypoglycemia (plasma glucose < 3.0 mmol/L, insulin > 3 μIU/mL, C-peptide > 0.6 ng/mL)
- surgical or biopsy-confirmed insulinoma or non-insulinoma pancreatogenous hypoglycemia syndrome, with definitive clinical diagnosis at discharge and comprehensive evaluation for hypoglycemia etiology during hospitalization.
Key exclusion criteria (2 listed)
- unknown etiology of hypoglycemia at last follow-up
- patients clinically diagnosed with insulinoma but without subsequent surgical intervention or biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between clinical indicators and PET/CT results
Time frame: 2 years
Correlation analysis of clinical biochemical indicators, endoscopic ultrasound, contrast-enhanced CT, contrast-enhanced MRI with ¹⁸F-Exendin-4 PET/CT results.
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 15 Jan 2026.
Related trials for Insulinoma
RecruitingObservational study
Diagnosing and Treating Low Blood Sugar Levels
Hypoglycemia, Insulinoma
RecruitingPhase 3
A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism
Tumor Hyperinsulinism (Tumor HI)
Recruiting
Comparison of [68Ga]Ga-HBED-CC-PEG6-Exendin-4 and [68Ga]Ga-HBED-CC-Exendin-4 PET/CT for Insulinoma Localization
Insulinoma
RecruitingObservational study
Glucagon-like Peptide-1 Receptor PET/CT in GLP-1R Related Disease
GLP1-R-related Disease, Tumor
RecruitingObservational study
Safety and Efficacy of EUS-RFA in Pancreatic Insulinoma
Insulinoma; Pancreas
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?
An observational study of Insulinoma, run by Sichuan Provincial People's Hospital 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 2 inclusion and 2 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 15 Jan 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.
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?
Correlation between clinical indicators and PET/CT results (time frame: 2 years). 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 15 Jan 2026.