18FDOPA PET/MRI for Hyperinsulinism
(18FDOPA HI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of the study is to provide access to 18F-DOPA PET to patients at Washington University and assess the utility of 18F-DOPA PET/MRI as a preoperative tool to detect and localize focal lesions in the pancreas that are causing hyperinsulinism.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It seems likely that you may continue your medications unless advised otherwise by your doctor.
Is 18FDOPA PET/MRI safe for humans?
The safety of 18FDOPA PET/MRI specifically isn't detailed in the provided articles, but MRI contrast agents generally have a good safety record. Gadolinium-based agents, commonly used in MRI, have been linked to a rare condition in patients with severe kidney issues, but new guidelines have minimized this risk.12345
How is the 18F-FDOPA PET/MRI treatment different from other treatments for hyperinsulinism?
The 18F-FDOPA PET/MRI treatment is unique because it uses a special imaging technique to detect areas of the pancreas with abnormal insulin production, which can help in precisely locating and treating focal forms of hyperinsulinism. This approach is particularly useful for identifying specific areas that may require surgical intervention, unlike other treatments that may not provide such detailed localization.678910
What data supports the effectiveness of the treatment 18F-FDOPA PET/MRI Imaging for hyperinsulinism?
Who Is on the Research Team?
Ana Maria Arbelaez
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Imaging
Participants undergo 18F-DOPA PET/MRI imaging to detect and localize focal lesions in the pancreas
Follow-up
Participants are monitored for safety and effectiveness after imaging and potential surgery
What Are the Treatments Tested in This Trial?
Interventions
- 18F-Fluoro Dopa PET/MRI Imaging
18F-Fluoro Dopa PET/MRI Imaging is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
St. Louis Children's Hospital
Collaborator