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

Fujian Medical University (FJMU)

Status and phase: Enrolling; Phase 1

Conditions: Insulinoma

Treatments: Drug: 68Ga-NOTA-exendin-4

Study type: Interventional

Funder types: Other

Identifiers

NCT04979611

FirstAHFujian11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 6 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Patients will undergo 68Ga-NOTA-exendin-4 PET/CT imaging

Other group

Description:

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.

Treatment:

Drug: 68Ga-NOTA-exendin-4