NCT05088798RecruitingPhase 2
Utility of 18FDOPA PET/MRI for Focal Hyperinsulinism
Use of18F-DOPA PET/MRI for the Detection and Localization of Focal Forms of Hyperinsulinism
Source: ClinicalTrials.gov · Last updated 19 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 18 Jun 2021
- Start date
- 10 Sept 2020
- Primary completion date
- 1 Jan 2030
- Lead sponsor
- Washington University School of Medicine
- NCT number
- NCT05088798
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 10 Sept 2020 to the primary completion date, 1 Jan 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Cases in which surgery will not be considered by parents or guardians.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.