NCT05088798 · Washington University School of Medicine
Utility of 18FDOPA PET/MRI for Focal Hyperinsulinism
(18FDOPA HI)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
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 measures
Increase Access to 18F-DOPA PET/MRI (or PET/CT) for patients with HI who failed medical therapy
Time frame: one year
To provide access to 18F-DOPA PET/MRI (or PET/CT) for patients with HI who do not respond to pharmacological therapy and are being considered for pancreatic surgery. We will measure this by totaling the number of scans performed yearly.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- St Louis, Missouri
Collaborators
St. Louis Children's Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 19, 2025 · Source of record for eligibility and locations