Insulinoma, Nesidioblastosis
Conditions
Keywords
PET/CT, glucagon-like peptide-1 receptor (GLP-1R) imaging
Brief 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.
Detailed 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.
Interventions
68Ga-NOTA-exendin-4 were injected into the patients before the PET/CT scans
Sponsors
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standardized uptake value of 68Ga-NOTA-exendin-4 PET/CT in Diagnosis of Insulinoma and Nesidioblastosis | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events collection | 1 week | Adverse events within 1 week after the injection and scanning of patients will be followed and assessed |
Countries
China
Contacts
Primary ContactFang Li, MD
Backup ContactYaping Luo, MD
Outcome results
None listed