Utility of 18FDOPA PET/MRI for Focal Hyperinsulinism

ConditionHyperinsulinism

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

18F-Fluoro Dopa PET/MRI Imaging
Drug
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.

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: 18F-Fluoro Dopa ImagingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Increase Access to 18F-DOPA PET/MRI (or PET/CT) for patients with HI who failed medical therapy

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.

Time frame

one year

Secondary outcomes

Accuracy of 18FDOPA PET/MRI to identify focal forms of hyperinsulinism that may be cured by surgery

To identify if data from 18FDOPA PET/MRI imaging can accurately diagnose focal forms of HI when compared to the gold-standard of histopathological findings obtained at surgery in subjects who received a partial or complete pancreatectomy. Currently this type of isotope is not available for diagnosis, of insulinomas.

Time frame

one year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

St. Louis Children's Hospital

Collaborator

Source ClinicalTrials.gov

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