Clinical Trial: 18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
Brief Summary:
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.
Detailed Summary:
Sponsor: University of Alberta
Current Primary Outcome: Immediate safety evaluation [ Time Frame: Within 1 hour of injection ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Delayed safety evaluation [ Time Frame: 10-14 days after injection ]A telephone survey to evaluate for delayed adverse reactions to 18F-DOPA injection
- Delayed safety evaluation - referring physician [ Time Frame: 6 months after injection ]Questionnaire for referring physician to screen for adverse reactions to 18F-DOPA injection
- Biodistribution: scan interpreter will evaluate the distribution of tracer and comment if expected [ Time Frame: Within 3 days after injection ]Scan interpreter will evaluate the distribution of tracer and comment if expected
- Perceived clinical benefit [ Time Frame: 6 months after injection ]Questionnaire for referring physician to assess perceived clinical benefit of scan
Original Secondary Outcome: Same as current
Information By: University of Alberta
Dates:
Date Received: February 1, 2017
Date Started: May 1, 2017
Date Completion: December 31, 2022
Last Updated: May 1, 2017
Last Verified: February 2017
