Utility of 18FDOPA PET/MRI for Focal Hyperinsulinism

Recruiting now · Phase 2

Conditions studied: Hyperinsulinism

In brief

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.

Key facts

Study ID

NCT05088798

Run by

Washington University School of Medicine

People needed

100

Starts

2020-09-10

Expected to finish

2030-01-01

Last updated by the study team

2025-12-19

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Washington University — St Louis, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.