Congenital Hyperinsulinism Clinical Trial
— DOPA PETOfficial title:
18F-Fluoro-L- DOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism
Verified date | June 2023 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this project is to determine the role of FDOPA/PET as a pre-operative diagnostic imaging procedure for differentiating focal and diffuse forms of congenital hyperinsulinism and locating focal lesions in the pancreas to guide surgical resection.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Days to 18 Years |
Eligibility | Inclusion Criteria: - Any age, but primarily infants 0-6 months given typical age of initial presentation. - Children with diagnosis of FoHI or DiHI based on clinical criteria (fasting hypoglycemia accompanied by inadequate suppression of plasma insulin, inappropriately low plasma free fatty acid and plasma-hydroxybutyrate concentrations, and an inappropriate glycemic response to glucagon injection) o confirmed by genetic testing for mutations in ABCC8 and KCNJ1 was1. - Hypoglycemia uncontrolled with medical management (diazoxide, octreotide). - Able to withdraw medications in time to wash out prior to the scheduled PET scan. - Patients fulfilling criteria above but with uncontrolled hypoglycemia after initial surgical management (partial or near-total pancreatectomy) - Normal hepatic and renal function. Exclusion Criteria: - Treatment with other, third-line, medications for hyperinsulinism (nifedipine, glucagon). - Patients with hepatic or renal insufficiency. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Miguel Pampaloni |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity of Imaging | To determine the sensitivity and specificity of FDOPA PET/CT in differentiating focal and diffuse forms of HI in infants with medically refractory hypoglycemia | four weeks | |
Primary | Accuracy of Imaging | To determine the accuracy of FDOPA PET/CT localizing areas of islet cell adenomatosis within the pancreas in patients with focal HI, by identifying the area of abnormal uptake of the raioligand | four weeks | |
Secondary | Semiquantitative Imaging Assessment | o determine whether data from FDOPA PET/CT can accurately quantify pancreatic islet cell mass in patients with HI (normal pancreas, areas of adenomatosis in focal HI and diseased pancreas in diffuse HI) by quantifying the standardized uptake value (SUV) of FDOPA of and correlating with histologic findings. | four weeks |
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