Clinical Trial · NCT04185350

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

Overview

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.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Phase

Early Phase 1

Contacts

Feng Wang, Ph.D (CONTACT)

fengwangcn@hotmail.com

+8602552271491

Feng Wang, Ph.D (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT04185350

Drug / Compound

NOTA-MAL-Cys39-exendin-4

Isotope(s):

Target(s):

Glucagon-Like Peptide-1 Receptor (GLP1R)

Ligand Class: Peptides

Chelator: NOTA

Linker: MAL

Eligibility

Inclusion

Conventional imaging within 3 month.
Biochemically proven endogenous hyperinsulinemic hypoglycaemia (plasma glucose concentration \<3.0 mM, insulin \>3 µU/ml, and C-peptide \>0.6 ng/ml);
Patients with hypoglycaemia in the presence of neuroglycopenic symptoms and documented Whipple's triad;

Exclusion

Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance.
Renal function: serum creatinine \> 3.0 mg/dl;
Breast feeding;
Pregnancy or the wish to become pregnant within 6 months;
Having a history of allergy to similar drugs, allergic constitution or suffering from allergic diseases;