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Radiopharmaceutical

18FDOPA PET/MRI for Hyperinsulinism (18FDOPA HI Trial)

Phase 2
Recruiting
Led By Ana Maria Arbelaez, MD, MSCI
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with confirmed hyperinsulinemic hypoglycemia, diagnosed by elevated insulin levels during hypoglycemia and/or response to glucagon stimulation
Subjects who failed pharmacological therapy with diazoxide or octreotide
Must not have
Cases in which surgery will not be considered by parents or guardians
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
No Placebo-Only Group

Summary

This trial will provide access to 18F-DOPA PET to patients with suspected focal lesions in the pancreas. The goal is to use 18F-DOPA PET/MRI to detect and localize these lesions, which will help guide surgery.

Who is the study for?
This trial is for patients with hyperinsulinemic hypoglycemia who can't be managed safely with standard treatments and need surgery. They must have high insulin levels during low blood sugar episodes or respond to glucagon stimulation, have failed therapy with diazoxide or octreotide, and provide informed consent.
What is being tested?
The study tests the use of a special imaging technique called 18F-Fluoro Dopa PET/MRI to find and pinpoint focal lesions in the pancreas causing hyperinsulinism before surgery at Washington University.
What are the potential side effects?
While not explicitly listed, potential side effects may include reactions related to the PET/MRI contrast agent used (like mild allergic reactions), discomfort from lying still during imaging, and exposure to radiation typical of such scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with low blood sugar due to high insulin levels.
Select...
I have tried diazoxide or octreotide for my condition without success.
Select...
My doctor recommends surgery because standard treatments for my low blood sugar haven't worked.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
Surgery is not an option for me as decided by my parents or guardians.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Increase Access to 18F-DOPA PET/MRI (or PET/CT) for patients with HI who failed medical therapy
Secondary study objectives
Accuracy of 18FDOPA PET/MRI to identify focal forms of hyperinsulinism that may be cured by surgery

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: 18F-Fluoro Dopa ImagingExperimental Treatment1 Intervention
single arm

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,988 Previous Clinical Trials
2,295,534 Total Patients Enrolled
St. Louis Children's HospitalOTHER
29 Previous Clinical Trials
87,722 Total Patients Enrolled
Ana Maria Arbelaez, MD, MSCIPrincipal InvestigatorWashington University School of Medicine

Media Library

18F-Fluoro Dopa PET/MRI Imaging (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT05088798 — Phase 2
Hyperinsulinemia Research Study Groups: 18F-Fluoro Dopa Imaging
Hyperinsulinemia Clinical Trial 2023: 18F-Fluoro Dopa PET/MRI Imaging Highlights & Side Effects. Trial Name: NCT05088798 — Phase 2
18F-Fluoro Dopa PET/MRI Imaging (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05088798 — Phase 2
~55 spots leftby Jan 2030
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