Parkinson Disease Clinical Trial
Official title:
18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
Verified date | January 2022 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 400 |
Est. completion date | June 2, 2021 |
Est. primary completion date | March 5, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta Hospital | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta | Alberta Health Services |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immediate safety evaluation | Clinical screen for adverse reactions to 18F-DOPA injection | Within 1 hour of injection | |
Secondary | Delayed safety evaluation | A telephone survey to evaluate for delayed adverse reactions to 18F-DOPA injection | 10-14 days after injection | |
Secondary | Delayed safety evaluation - referring physician | Questionnaire for referring physician to screen for adverse reactions to 18F-DOPA injection | 6 months after injection | |
Secondary | 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 | |
Secondary | Perceived clinical benefit | Questionnaire for referring physician to assess perceived clinical benefit of scan | 6 months after injection |
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