Comparison of [68Ga]Ga-HBED-CC-PEG6-Exendin-4 and [68Ga]Ga-HBED-CC-Exendin-4 PET/CT for Insulinoma Localization

What Was Tested

In this not phased trial, researchers set out to test Exenatide.

This clinical research evaluates a new PET/CT imaging agent, \[68Ga\]Ga-HBED-CC-PEG6-exendin-4, for localizing insulinoma, a rare pancreatic tumor that causes severe low blood sugar.

Insulinomas are often small and hard to detect with regular CT, ultrasound or standard PET scans.

It had 1 arm (groups): Single Arm: Dual PET/CT Imaging with [68Ga]Ga-HBED-CC-PEG6-exendin-4 and [68Ga]Ga-HBED-CC-exendin-4 (experimental).

The registry classes the interventions as diagnostic test.

More on the Plan

Insulinoma is the most common cause of endogenous hyperinsulinemic hypoglycemia in adults.

Most lesions are benign but typically small (1-2 cm), leading to poor detection sensitivity for conventional cross-sectional imaging including abdominal ultrasound and routine CT, which frequently fails to pinpoint tiny tumor foci.

Incomplete resection results in persistent hypoglycemic symptoms and poor quality of life, creating an urgent clinical demand for sensitive, noninvasive localization modalities.

Glucagon-like peptide-1 receptor (GLP-1R) is abundantly overexpressed on benign insulinoma cells at levels approximately five times higher than normal pancreatic beta cells, making it an ideal molecular target for positron emission tomography.

Who Took Part

Enrollment: 20 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age between 18 and 70 years, male or female. Clinically suspected insulinoma with biochemically proven endogenous hyperinsulinism. Complete clinical information and conventional abdominal imaging data available. Scheduled for pancreatic surgery or biopsy within 30 days after PET/CT examination for pathological confirmation. Capable of completing two GLP-1R-targeted PET/CT scans within a 7-day interval.

The full record lists 6 inclusion and 4 exclusion criteria; among the exclusions: pregnancy, suspected pregnancy, or lactating status; severe hepatic or renal dysfunction prohibiting radiotracer injection; known allergy or hypersensitivity to exendin-4, gallium-based tracers, or injection excipients.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label Exenatide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2026-10-01 with completion listed for 2027-08-31.

It ran at 1 site in China.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: Diagnostic performance comparison between two GLP-1R PET tracers for insulinoma localization (time frame: Up to 2 months after subjects complete both PET/CT scans and obtain pathological biopsy/surgical results). Diagnostic performance comparison between two GLP-1R PET tracers for insulinoma localization (time frame: Up to 2 months after subjects complete both PET/CT scans and obtain pathological biopsy/surgical results). Diagnostic performance comparison between two GLP-1R PET tracers for insulinoma localization (time frame: Up to 2 months after subjects complete both PET/CT scans and obtain pathological biopsy/surgical results).

It also tracked 4 secondary outcomes, for example Comparison of tumor-to-background ratios of the two GLP-1R radiotracers, Comparison of renal uptake of the two GLP-1R radiotracers, Area under plasma radioactivity concentration-time curve (AUC0-t) and Internal radiation dosimetry of [68Ga]Ga-HBED-CC-PEG6-exendin-4.

What This Means in Plain Language

Put simply, this is a not phased trial of Exenatide in 20 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, all human trials.