Single centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific patient populations: 1. Pediatric patients with congenital hyperinsulinism 2. Pediatric patients with neuroblastoma 3. Pediatric or Adult patients with suspected extra-pancreatic neuroendocrine tumor 4. Adult patients with a clinical suspicion of Parkinson's disease 5. Pediatric or Adult patients with primary brain tumors This study will evaluate the biodistribution and safety of 18F-DOPA produced at the Edmonton PET Centre.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
400
18F-DOPA intravenous injection single dose
University of Alberta Hospital
Edmonton, Alberta, Canada
Immediate safety evaluation
Clinical screen for adverse reactions to 18F-DOPA injection
Time frame: Within 1 hour of injection
Delayed safety evaluation
A telephone survey to evaluate for delayed adverse reactions to 18F-DOPA injection
Time frame: 10-14 days after injection
Delayed safety evaluation - referring physician
Questionnaire for referring physician to screen for adverse reactions to 18F-DOPA injection
Time frame: 6 months after injection
Biodistribution: scan interpreter will evaluate the distribution of tracer and comment if expected
Scan interpreter will evaluate the distribution of tracer and comment if expected
Time frame: Within 3 days after injection
Perceived clinical benefit
Questionnaire for referring physician to assess perceived clinical benefit of scan
Time frame: 6 months after injection
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