Actively Recruiting
18F-Fluoro-L-DOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism
Led by Miguel Pampaloni · Updated on 2026-05-01
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of 18F-Fluoro-L-DOPA PET imaging as a pre-operative tool to distinguish between focal and diffuse forms of congenital hyperinsulinism (HI) and to locate focal lesions in the pancreas. Congenital hyperinsulinism is a common cause of persistent low blood sugar in infants, often requiring surgery when medications do not work. Identifying focal lesions before surgery could help guide pancreatic resection more accurately. The study involves imaging patients diagnosed with congenital hyperinsulinism using 18F-Fluoro Dopa PET scans. This imaging technique is being assessed for its ability to detect and locate diseased areas in the pancreas. The trial is a single-arm phase 2 study where all participants receive the 18F-Fluoro Dopa imaging. Participants must stop certain medications before the scan to ensure accurate imaging results. Participants will undergo the PET scan, and researchers will measure the sensitivity and accuracy of the imaging within four weeks. Additional semi-quantitative assessments will also be performed. The study includes infants and children up to 18 years old, with careful monitoring of liver and kidney function. The total time for outcome measurement is four weeks after imaging to evaluate its diagnostic performance.
CONDITIONS
Brief Title
18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants of any age, primarily infants 0-6 months old
- Diagnosis of focal or diffuse congenital hyperinsulinism confirmed by clinical criteria and genetic testing for ABCC8 or KCNJ1 mutations
- Hypoglycemia not controlled with medical management such as diazoxide or octreotide
- Ability to stop medications before the PET scan
- Patients with uncontrolled hypoglycemia after initial pancreatic surgery
- Normal liver and kidney function
You will not qualify if you...
- Treatment with third-line medications for hyperinsulinism such as nifedipine or glucagon
- Presence of liver or kidney insufficiency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single day
Participants undergo 18F-Fluoro Dopa PET imaging to detect and localize focal congenital hyperinsulinism.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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