← Back to Search

FDOPA/PET Imaging for Congenital Hyperinsulinism (DOPA PET Trial)

Phase 2
Recruiting
Led By Miguel Hernandez Pampaloni, MD, PhD
Research Sponsored by Miguel Pampaloni
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal hepatic and renal function
Hypoglycemia uncontrolled with medical management (diazoxide, octreotide)
Must not have
Treatment with other, third-line, medications for hyperinsulinism (nifedipine, glucagon)
Patients with hepatic or renal insufficiency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up four weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will use FDOPA/PET to see if it can help doctors better understand and treat congenital hyperinsulinism, a disorder where the pancreas produces too much insulin.

Who is the study for?
This trial is for anyone, especially infants aged 0-6 months with uncontrolled hypoglycemia due to congenital hyperinsulinism, who have normal liver and kidney function. It's not for those on certain third-line hyperinsulinism medications or with liver/kidney insufficiency.
What is being tested?
The study tests if a special PET scan using FDOPA can tell apart different types of congenital hyperinsulinism and pinpoint lesions in the pancreas before surgery.
What are the potential side effects?
While the document doesn't specify side effects, generally PET scans are considered safe; possible side effects may include discomfort from lying still during the procedure or reactions to the tracer.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My liver and kidney functions are normal.
Select...
My low blood sugar levels are not controlled by medication.
Select...
My child has a genetic form of hypoglycemia confirmed by tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am taking third-line medications like nifedipine or glucagon for hyperinsulinism.
Select...
I have liver or kidney problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and four weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Accuracy of Imaging
Sensitivity of Imaging
Secondary study objectives
Semiquantitative Imaging Assessment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Arm,Experimental Treatment1 Intervention
Patients with clinically diagnosed congenital hyperinsulinism

Find a Location

Who is running the clinical trial?

Miguel PampaloniLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Miguel Hernandez Pampaloni, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco

Media Library

18F-Fluoro Dopa Imaging Clinical Trial Eligibility Overview. Trial Name: NCT04205604 — Phase 2
Congenital Hyperinsulinism Research Study Groups: Single Arm,
Congenital Hyperinsulinism Clinical Trial 2023: 18F-Fluoro Dopa Imaging Highlights & Side Effects. Trial Name: NCT04205604 — Phase 2
18F-Fluoro Dopa Imaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT04205604 — Phase 2
~6 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top