The Clinical Application of 68Ga-NOTA-exendin-4 PET/CT in Detecting Insulinoma

Phase 1

Recruiting

• Conditions: Insulinoma
• Interventions: Drug: 68Ga-NOTA-exendin-4

• Registration Number: NCT04979611
• Lead Sponsor: First Affiliated Hospital of Fujian Medical University

Brief Summary

The small insulinoma can not be detected by the CT or MRI. We use 68Ga-NOTA-exendin-4 positron emission tomography/computed tomography (PET/CT) to detect the insulinoma for the patient diagnosed with endogenous hyperinsulinemic hypoglycaemia. And the diagnostic value will be performed. A single dose of 37-111 Mega-Becquerel (MBq) 68Ga-NOTA-exendin-4 will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

Detailed Description

The glucagon-like peptide-1 receptor (GLP-1R) is an emerging target due to its high expression in benign insulinomas. 68Ga-NOTA-exendin-4 is an optimal probe targeting GLP-1R. The clinical use of 68Ga-NOTA-exendin-4 PET/CT in detecting insulinomas will be evaluated. And the comparation between PET diagnostic value and CT / MRI will be done.

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-07-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-21
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1.age ≥6 years old 2.Patients with hypoglycaemia 3.Endogenous hyperinsulinemic hypoglycaemia 4.Enhanced CT or MRI within 1 month 5.Signed written consent

Exclusion Criteria

• 1. Breast feeding 2.Pregnancy or the wish to become pregnant within 6 months 3.Renal function: serum creatinine during 41-73umol/L 4.Any medical condition may significantly interfere with study compliance; 5.Known allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients will undergo 68Ga-NOTA-exendin-4 PET/CT imaging	68Ga-NOTA-exendin-4	A single dose of 37-111 Mega-Becquerel (MBq) 68Ga-NOTA-exendin-4 will be injected intravenously. PET/CT imaging will be performed at 30-60 min post-injection.Visual and semiquantitative method will be used to assess the PET/CT images.

Primary Outcome Measures

Name	Time	Method
Standard uptake value (SUV)	From right after tracer injection to 1-hours post-injection	Determination of SUV for detected lesions and discernible organs of 68Ga-NODAGA-JR11 and 68Ga-DOTATATE Standard uptake value (SUV) of the lesion will be recorded

Trial Locations

Locations (1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China