Overview

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.