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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up four weeks
Awards & highlights

DOPA PET Trial 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.Check my eligibility
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.See study design
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.

DOPA PET Trial Eligibility Criteria

Inclusion Criteria

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

DOPA PET Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Accuracy of Imaging
Sensitivity of Imaging
Secondary outcome measures
Semiquantitative Imaging Assessment

DOPA PET 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is 18F-Fluoro Dopa Imaging cleared by the FDA?

"There has not been a clinical trial testing the efficacy of 18F-Fluoro Dopa Imaging, however, there is evidence that it is safe. As such, our team scored it as a 2."

Answered by AI

Does this research involve human subjects?

"This study is looking for 50 children that have been diagnosed with congenital hyperinsulinism. All potential participants must meet the age criteria of 0 days to 18 years old. In addition, they must also satisfy the following: uncontrolled hypoglycemia after initial surgical management (partial or near-total pancreatectomy), any age but primarily infants 0-6 months given typical age of initial presentation., able to withdraw medications in time to wash out prior to the scheduled PET scan."

Answered by AI

Do the age limits for this research include elderly citizens?

"To be eligible for this study, potential participants must fall in the age bracket of 0 days to 18 years old. There are a total of 7 clinical trials underway for patients that young and 11 studies recruiting people over the age of 65."

Answered by AI

Are participants still being accepted for this research project?

"That is accurate. The information available from clinicaltrials.gov suggests that the research team is still recruiting patients for this study, which was first posted on November 3rd 2016. The trial is seeking 50 individuals total, at a single location."

Answered by AI

How many individuals are being given this opportunity to participate in the research?

"The clinical trial is currently looking for candidates, according to the information on clinicaltrials.gov. The date the clinical trial was originally posted was 11/3/2016, and it was most recently updated on 5/16/2022. The number of patients being enrolled in this study across 1 location is 50."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism
Miguel Pampaloni 2016. "18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04205604.
~6 spots leftby Apr 2025
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