[68Ga]Ga-HBED-CC-exendin-4 and [68Ga]Ga-NOTA-exendin-4 PET/CT Imaging in the Same Group of Insulinoma Patients

What Was Tested

This registered early phase 1 trial tested Exenatide.

This pilot study was prospectively designed to evaluate the early dynamic distribution of \[68Ga\]Ga-HBED-CC-exendin-4, a novel radiopharmaceutical targeting GLP-1R, which was compared with \[68Ga\]Ga-NOTA-exendin-4 in the same group of insulinoma patients.

It had 1 arm (groups): [68Ga]Ga-HBED-CC-exendin-4 and [68Ga]Ga-NOTA-exendin-4 PET/ CT scan (experimental).

Patients of Insulinoma PET/CT imaging: In two consecutive days each patient underwent a 60-min dynamic PET/CT scan after intravenous administration of \[68Ga\]Ga-HBED-CC-exendin-4 and \[68Ga\]Ga-NOTA-exendin-4, respectively.

The registry classes the interventions as drug.

More on the Plan

Insulinoma is the most common cause of endogenous hyperinsulinemic hypoglycemia in adult patients without diabetes.

The only curative treatment of an insulinoma is its surgical removal.

Therefore, exact preoperative localization of the insulinoma is critical to planning the surgical intervention.

MR imaging, CT, or endoscopic ultrasound is normally used to localize insulinomas.

Who Took Part

The registry lists 20 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Confirmed treated or untreated insulinoma patients;. \[68Ga\]Ga-HBED-CC-exendin-4 and \[68Ga\]Ga-NOTA-exendin-4 PET/CT within two consecutive days;. Signed written consent.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: known allergy against exendin-4;.

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 2021-10-01 with completion listed for 2022-10-13.

It ran at 1 site in China.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: Metabolic parameters (time frame: through study completion, an average of 1 year).

It also tracked 1 secondary outcome, for example Diagnostic value.

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Exenatide in 20 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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