Clinical trial
Use of18F-DOPA PET/MRI for the Detection and Localization of Focal Forms of Hyperinsulinism
Name
201801029
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.
Trial arms
Trial start
2020-09-10
Estimated PCD
2030-01-01
Trial end
2030-01-01
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
18F-Fluoro Dopa Imaging
Other names:
6-[18F]-Fluoro-L-3,4,-dihydroxyphenylalanine, 18F-DOPA, [18F]-Fluorodopa
Size
100
Primary endpoint
Increase Access to 18F-DOPA PET/MRI (or PET/CT) for patients with HI who failed medical therapy
one year
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-07-27
1 organization
1 product
1 indication
Organization
Washington University School of MedicineIndication
Hyperinsulinism