Using 18F-DOPA PET/MRI to find causes of hyperinsulinism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of 18F-DOPA PET/MRI imaging as a preoperative tool for detecting and localizing focal lesions in the pancreas that cause hyperinsulinism in patients. Congenital hyperinsulinism is a serious condition leading to severe hypoglycemia in infants and children, and many patients with focal disease can benefit from surgical intervention. The study will involve patients who have not responded to standard pharmacological treatments and are being considered for surgery. By accurately identifying the lesions, the study seeks to improve surgical outcomes and patient safety.

Why it matters

Who can join: the full rules

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.

Where it's running

• Washington University
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Ana Maria Arbelaez, MD, MSCI — Washington University School of Medicine
• Study coordinator: Pamela S Stone, RN
• Email: stone.p@wustl.edu
• Phone: 314-747-4659

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.