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

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborator: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
• Treatments: Exenatide

Criteria

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.