RecruitingPhase 2NCT05088798

Utility of 18FDOPA PET/MRI for Focal Hyperinsulinism

Use of18F-DOPA PET/MRI for the Detection and Localization of Focal Forms of Hyperinsulinism


Sponsor

Washington University School of Medicine

Enrollment

100 participants

Start Date

Sep 10, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Inclusion Criteria5

  • 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.
  • Cases in which surgery will not be considered by parents or guardians.

Exclusion Criteria1

  • 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.

Interventions

DRUG18F-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.


Locations(1)

Washington University

St Louis, Missouri, United States

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NCT05088798


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