Congenital Hyperinsulinism Clinical Trials

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18F-Fluoro-L- DOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism

Who is this study for? Patients with Congenital Hyperinsulinism
What treatments are being studied? 18F-Fluoro Dopa Imaging
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Time Frame
Start Date: 2016-11-03
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 50
Treatments
Experimental: Single Arm,
Patients with clinically diagnosed congenital hyperinsulinism
Sponsors
Leads: Miguel Pampaloni

This content was sourced from clinicaltrials.gov

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