Utility of 18FDOPA PET/MRI for Focal Hyperinsulinism
ConditionHyperinsulinism
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorWashington University School of Medicine
About 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.
Eligibility criteria
Qualifiers
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.
Subjects 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 to prevent future episodes of severe hypoglycemia and preserve brain function.
Disqualifiers
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.
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.
Cases in which surgery will not be considered by parents or guardians.
Trial design
Treatments tested in this trial
- 18F-Fluoro Dopa PET/MRI Imaging
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Washington University School of Medicine
Lead sponsor
St. Louis Children's Hospital
Collaborator
Source ClinicalTrials.gov