Congenital HyperinsulinismDiagnostics and screeningRare diseaseNewbornChildren's healthDrugPhase 2
What this study is
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.
What's being tested
- 18F-Fluoro Dopa Imaging
Intervention · DRUG
Imaging with 18F-Fluoro Dopa PET Imaging
Study details
- Official title
- 18F-Fluoro-L- DOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism
- Sponsor
- Miguel Pampaloni
- Conditions
- Congenital Hyperinsulinism
- Enrolling
- 50 people
- Starts
- 2016-11-03
- Est. completion
- 2026-12-01
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 0 Days – 18 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- Treatment with other, third-line, medications for hyperinsulinism (nifedipine, glucagon).
- Patients with hepatic or renal insufficiency.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openUniversity of California, San Francisco
San Francisco, California, United States
- Miguel Hernandez Pampaloni, MD, PhD · Contact415-353-1886
Recruiting
Study team
Sponsor
Miguel Pampaloni
Study ID 8F-Fluoro-L- DOPA
Principal investigator
Miguel Hernandez Pampaloni, MD, PhD
University of California, San Francisco
Have questions? The record lists no central contact. Use Consider me and the site team can reach you, or find them through ClinicalTrials.gov ↗.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.