Clinical Study of 18F-Exendin-4 in Insulinoma

January 14, 2026 updated by: Hao Wang, Sichuan Provincial People's Hospital

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chengdu, China
        • Department of Endocrinology and Department of Nuclear Medicine, Sichuan Provincial People's Hospital, Chengdu, Sichuan 610072

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with diagnosed or highly suspected insulinoma.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • unknown etiology of hypoglycemia at last follow-up
  • patients clinically diagnosed with insulinoma but without subsequent surgical intervention or biopsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

October 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Estimated)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SichuanPPH-Insulinoma

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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