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Utility of 18FDOPA PET/MRI for Focal Hyperinsulinism
RecruitingPhase 2
Use of18F-DOPA PET/MRI for the Detection and Localization of Focal Forms of Hyperinsulinism
Who can join
All ages · All sexes
Full eligibility criteria
Inclusion Criteria: 1. Patients with confirmed hyperinsulinemic hypoglycemia, diagnosed by elevated insulin levels during hypoglycemia and/or response to glucagon stimulation. 2. Subjects who failed pharmacological therapy with diazoxide or octreotide. 3. Subjects with signed informed consent by themselves or their parents or legal guardians. 4. Patient's Endocrinologist has determined that the patient cannot be safely managed with standard medical therapy (failed) and surgery is recommended to prevent future episodes of severe hypoglycemia and preserve brain function. Exclusion Criteria: 1. Any other major illness or condition that in the investigator's judgment will substantially increase the risk associated with the subject's participation in this study. 2. Patient must not have any contraindication to MRI as evaluated by a standardized MRI safety questionnaire. If MRI is contraindicated, and patient meets inclusion criteria and has no other contraindications study will be conducted in PET/CT scanner. 3. Cases in which surgery will not be considered by parents or guardians.
About the study
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.
What is being tested
- 18F-Fluoro Dopa PET/MRI Imaging (drug)
Sponsor: Washington University School of Medicine · Participants: 100 · Started: Sep 10, 2020
Contact the study team
- Pamela S Stone, RN · Phone: 314-747-4659
- Ana Maria Arbelaez, MD, MSCI · Phone: 314-286-1138
Official record on ClinicalTrials.gov — NCT05088798
Locations in the U.S.
| Missouri | Washington University, St Louis |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.