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New treatment option for Hyperinsulinism
Official title Utility of 18FDOPA PET/MRI for Focal Hyperinsulinism
ClinicalTrials.gov ID: NCT05088798
What this study is testing
What is 18F-Fluoro Dopa PET/MRI Imaging?
18F-Fluoro Dopa PET/MRI Imaging is an investigational medicine, being studied as a potential treatment for hyperinsulinism.
Also referred to as 6-[18F]-Fluoro-L-3,4,-dihydroxyphenylalanine, 18F-DOPA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Patients with confirmed hyperinsulinemic hypoglycemia, diagnosed by elevated insulin levels during hypoglycemia and/or response to glucagon...
- people who failed pharmacological therapy with diazoxide or octreotide.
- people with signed informed consent by themselves or their parents or legal guardians.
- Patient's Endocrinologist has determined that the patient cannot be safely managed with standard medical therapy (failed) and surgery is recommended...
You likely can't join if
- Any other major illness or condition that in the investigator's judgment will substantially increase the risk associated with the subject's...
- Patient must not have any contraindication to MRI as evaluated by a standardized MRI safety questionnaire. If MRI is contraindicated, and patient...
- Cases in which surgery will not be considered by parents or guardians.
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.