Clinical Evaluation of 68Ga-NOTA-MAL-Cys39-exendin-4 Positron Emission Tomography in the Detection of Insulinoma

What Was Tested

The trial (early phase 1) is built around Exenatide.

Glucagon-like peptide-1 receptor (GLP-1R) is a kind of G protein coupled receptor which regulate the insulin secretion and serves as potential target in the diagnosis of functional pancreas neuroendocrine tumor.

The aim of this study was the clinical evaluation of a potential GLP-1R targeted tracer 68Ga-NOTA-MAL-Cys39-exendin-4 for the detection of insulinoma.

It had 1 arm (groups): 68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT (experimental).

The registry classes the interventions as drug.

More on the Plan

Since GLP-1R is expressed in human β-cells and highly overexpressed in insulinomas，multiple GLP-1R-targeted radiopharmaceuticals were devoted to insulinoma localization imaging.68Ga-NOTA-MAL-Cys39-exendin-4 is an optimal probe targeting GLP-1R.

Visual and semiquantitative method will be used to assess the PET/CT images.The investigators will determine the use of 68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT in the detection of insulinomas, and to compare its diagnostic value with conventional imaging.

Who Took Part

The registry lists 60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: The patient volunteers and signs an informed consent form. Age ≥18 and ≤75 years old;. Patients with hypoglycaemia in the presence of neuroglycopenic symptoms and documented Whipple's triad;. Biochemically proven endogenous hyperinsulinemic hypoglycaemia (plasma glucose concentration \<3.0 mM, insulin \>3 µU/ml, and C-peptide \>0.6 ng/ml);. Conventional imaging within 3 month.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: having a history of allergy to similar drugs, allergic constitution or suffering from allergic diseases;; breast feeding;; pregnancy or the wish to become pregnant within 6 months;.

How the Study Was Run

The set-up was single-group and open-label.

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 2019-05-05 with completion listed for 2020-04-05.

It ran at 1 site in China.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Standardized uptake value (time frame: 1 year).

It also tracked 2 secondary outcomes, for example GLP-1 receptor expression by histology compared to tracer uptake and Incidence of Adverse Events.

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Exenatide in 60 people.

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.