Utility of 18FDOPA PET/MRI for Focal Hyperinsulinism

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Oct 8, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a special imaging technique called 18F-DOPA PET/MRI to help find the source of a problem called hyperinsulinism, which is when the body produces too much insulin and can lead to dangerously low blood sugar levels. The goal is to see if this imaging tool can help doctors locate specific areas in the pancreas that might be causing this issue, which could lead to more effective treatment options, including surgery.

To participate in this study, patients must have been diagnosed with hyperinsulinism and have not responded well to certain medications. Additionally, their doctor must believe that surgery is the best option to prevent serious health problems. The trial is currently looking for participants of all ages, and those who join can expect to undergo scans that will help identify any problematic areas in the pancreas. It's important to note that if a patient cannot safely undergo an MRI, they may still be eligible to participate in the study using a different type of scan.

Gender

ALL

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.