18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety

Study Overview
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Brief Summary
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Single centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific patient populations: Pediatric patients with congenital hyperinsulinism Pediatric patients with neuroblastoma Pediatric or Adult patients with suspected extra-pancreatic neuroendocrine tumor Adult patients with a clinical suspicion of Parkinson's disease 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.

Official Title
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18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety

Conditions
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Congenital Hyperinsulinism, Neuroblastoma, Neuroendocrine Tumors, Parkinson Disease, Brain Glioma

Intervention / Treatment
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* Drug: 18F-DOPA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Pediatric patients (less than 17 years old) with congenital hyperinsulinism 2. Pediatric patients (less than 17 years old) with neuroblastoma 3. Pediatric patients (less than 17 years old) or Adult patients (17 or older) with known or clinically suspected neuroendocrine tumor outside of the pancreas 4. Adult patients (17 or older) with a clinical suspicion of Parkinson's disease. 5. Pediatric (less than 17 years old) or Adult patients (17 or older) with primary brain tumors Exclusion Criteria: Unable to obtain consent Weight > 250 kg (weight limitation of PET/CT scanner) Adult patients unable to lie flat for 20-30 minutes to complete the PET/CT scan Young pediatric patients (less than 10 years old) who are unable to lie flat for 20-30 minutes and for whom clinical sedation is contraindicated (as determined by a pediatric anaesthesiologist) Pregnancy Lack of intravenous access
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-DOPA scan<br>18F-DOPA (4 MBq/kg, minimum 110 MBq, maximum 600 MBq) intravenous. Single-dose 20-80 minutes prior to PET/CT scan of brain or whole body (depending on specific imaging protocol for patient). | Drug: 18F-DOPA<br>* 18F-DOPA intravenous injection single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate safety evaluation | Clinical screen for adverse reactions to 18F-DOPA injection | Within 1 hour of injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delayed safety evaluation | A telephone survey to evaluate for delayed adverse reactions to 18F-DOPA injection | 10-14 days after injection | 
| Delayed safety evaluation - referring physician | Questionnaire for referring physician to screen for adverse reactions to 18F-DOPA injection | 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 | Within 3 days after injection | 
| Perceived clinical benefit | Questionnaire for referring physician to assess perceived clinical benefit of scan | 6 months after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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18F-DOPA PET/CT