Recruiting
Phase 2

18F-DOPA PET

Sponsor:

Washington University School of Medicine

Code:

NCT05088798

Conditions

Hyperinsulinism

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

18F-Fluoro Dopa PET/MRI Imaging

Study Details

Brief summary:

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.

Conditions

Hyperinsulinism

Study ID

NCT05088798

Start date

Sep 10, 2020

Status verified date

Dec, 2025

Completion date

Jan 1, 2030

Anticipated

Primary completion date

Jan 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 18F-Fluoro Dopa Imaging

single arm

Interventions

18F-Fluoro Dopa PET/MRI Imaging

The purpose of this research study is to provide access to an imaging study of the pancreas that uses 6-\[18F\]-Fluoro-L-3,4,-dihydroxyphenylalanine (18F-DOPA)positron emission tomography (PET) and assess the accuracy of this 18F-DOPA-PET/MRI test on distinguishing what part of the pancreas is affected in patients with Hyperinsulinism.

Primary outcome measure

  • Increase Access to 18F-DOPA PET/MRI (or PET/CT) for patients with HI who failed medical therapy [ Time Frame: one year ]

Central Contacts and Locations

Central contacts

Pamela S Stone, RN

314-747-4659stone.p@wustl.edu

Ana Maria Arbelaez, MD, MSCI

314-286-1138aarbelaez@wustl.edu

Locations

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Ana M Arbelaez, MD

314-454-6051aarbelaez@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Dec 19, 2025

Last verified

Dec, 2025

Keywords

  • hypoglycemia
  • Glucose Metabolism Disorders
  • Infant, Newborn, Diseases
  • Hyperinsulinism
  • Insulinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2025-12-19.