NCT07340437

Clinical Study of 18F-Exendin-4 in Insulinoma

Clinical Study of an ¹⁸F-labeled GLP-1R Probe in Insulinoma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Sichuan Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Timeline

• Start date: 2023-02-01
• Primary completion: 2025-10-31
• Completion: 2025-12-31
• First posted: 2026-01-14
• Last updated: 2026-01-15

Locations

1 site across 1 country: China