← Back to Clinical Trials
Recruiting Phase 2 NCT05088798

Utility of 18FDOPA PET/MRI for Focal Hyperinsulinism

Trial Parameters

Condition Hyperinsulinism
Sponsor Washington University School of Medicine
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 100
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2020-09-10
Completion 2030-01-01
Interventions
18F-Fluoro Dopa PET/MRI Imaging

Brief Summary

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

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

Related Trials