Using 18F-DOPA PET/MRI to find causes of hyperinsulinism
Use of18F-DOPA PET/MRI for the Detection and Localization of Focal Forms of Hyperinsulinism
This study is testing if a special type of imaging can help find the exact spots in the pancreas that cause hyperinsulinism in kids who need surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT05088798 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include infants and children diagnosed with hyperinsulinemic hypoglycemia who have failed pharmacological therapy and are recommended for surgery.
Not a fit: Patients with contraindications to MRI or those with other major illnesses that increase participation risk may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the ability to localize pancreatic lesions, leading to better surgical outcomes for patients with hyperinsulinism.
How similar studies have performed: While the use of PET/MRI imaging is gaining traction, this specific application for hyperinsulinism is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
St Louis, Missouri
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.