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

• Status: Recruiting
• Trial end date: 2020-05-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University
• Treatments: Exenatide

Criteria

Inclusion Criteria:

1. The patient volunteers and signs an informed consent form.

2. age ≥18 and ≤75 years old;

3. Patients with hypoglycaemia in the presence of neuroglycopenic symptoms and documented Whipple's triad;

4. Biochemically proven endogenous hyperinsulinemic hypoglycaemia (plasma glucose concentration <3.0 mM, insulin >3 µU/ml, and C-peptide >0.6 ng/ml);

5. Conventional imaging within 3 month.

Exclusion Criteria:

1. Having a history of allergy to similar drugs, allergic constitution or suffering from allergic diseases;

2. Breast feeding;

3. Pregnancy or the wish to become pregnant within 6 months;

4. Renal function: serum creatinine > 3.0 mg/dl;

5. Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance.