68Ga-NOTA-exendin-4 PET/CT for the Localization of Insulinoma and Diagnosis of Nesidioblastosis

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Early Phase 1

Conditions: Insulinoma; Nesidioblastosis

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02560376

PUMCHNM12

ZIAEB000073 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-exendin-4 in insulinoma and nesidioblastosis patients. A single dose of 55.5-111 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

68Ga-NOTA-exendin-4 is an optimal probe targeting GLP-1R. The investigators will determine the use of 68Ga-NOTA-exendin-4 PET/CT in the detection of insulinomas, and to compare its diagnostic value with conventional imaging. GLP-1R imaging, specifically expressed on pancreatic beta cell surface, might help with diagnosis of different types of nesidioblastosis (ie. focal or diffuse type), and may improve the treatment strategy of nesidioblastosis. The investigator will determine the use of 68Ga-NOTA-exendin-4 PET/CT in differentiating nesidioblastosis.

Enrollment: 100 estimated patients

Sex: All

Ages: 6 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 1 month
• Signed written consent
• Age above 6 years (congenital hyperinsulinemic with the symptoms onset in school age is also the subject of this study)

Exclusion criteria

• Pregnancy
• Breastfeeding
• Renal function: serum creatinine > 3.0 mg/dl
• Known allergy against exendin-4
• Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

68Ga-NOTA-exendin-4 PET/CT

Experimental group

Description:

The patients were injected with 55.5-111 MBq of 68Ga-NOTA-exendin-4 PET/CT in one dose intravenously and underwent PET/CT scan 30-60 min later.

Treatment:

Drug: 68Ga-NOTA-exendin-4