Clinical trial
18F-Fluoro-L- DOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism
Name
8F-Fluoro-L- DOPA
Description
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.
Trial arms
Trial start
2016-11-03
Estimated PCD
2023-12-31
Trial end
2026-12-31
Status
Recruiting
Phase
Early phase I
Treatment
18F-Fluoro Dopa Imaging
Imaging with 18F-Fluoro Dopa PET Imaging
Arms:
Single Arm,
Size
50
Primary endpoint
Sensitivity of Imaging
four weeks
Accuracy of Imaging
four weeks
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2023-06-28
1 organization
1 product
1 indication
Organization
Miguel PampaloniProduct
18F-Fluoro DopaIndication
Congenital Hyperinsulinism