Using 18F-FluoroLDOPA PET imaging to find focal congenital hyperinsulinism
18F-Fluoro-L- DOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism
PHASE2 · University of California, San Francisco · NCT04205604
This study is testing if a special type of PET imaging can help doctors find specific areas in the pancreas of infants with congenital hyperinsulinism that can be surgically removed to improve their condition.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 0 Days to 18 Years |
| Sex | All |
| Sponsor | University of California, San Francisco (other) |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT04205604 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of 18F-FluoroLDOPA PET imaging as a pre-operative diagnostic tool for distinguishing between focal and diffuse congenital hyperinsulinism. The study focuses on locating focal lesions in the pancreas that can be surgically removed to treat the condition. Congenital hyperinsulinism often leads to severe hypoglycemia in infants, and current imaging methods are inadequate for identifying the specific areas of dysfunction. By utilizing PET imaging, the study seeks to improve surgical outcomes for affected patients.
Who should consider this trial
Good fit: Ideal candidates include infants and children diagnosed with focal or diffuse congenital hyperinsulinism who have uncontrolled hypoglycemia despite medical management.
Not a fit: Patients with hepatic or renal insufficiency or those treated with certain third-line medications for hyperinsulinism may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the ability to accurately diagnose and localize focal congenital hyperinsulinism, leading to more effective surgical interventions.
How similar studies have performed: Previous studies have shown promise in using PET imaging for similar diagnostic purposes, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (RECRUITING)
Study contacts
- Principal investigator: Miguel Hernandez Pampaloni, MD, PhD — University of California, San Francisco
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congenital Hyperinsulinism