Clinical trialPhase 3Completed
18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
- Outcome
- Finished, no results posted
- Phase
- Phase 3
- Status
- Completed
- Study type
- Interventional
- Start
- 29 June 2017
- Ended
- 2 June 2021
- Enrollment
- 400 participants
- Sites
- 1
- Primary outcomes
- Immediate safety evaluation
- Sponsor type
- Academic / other
- Results posted
- No
- Last update
- 10 January 2022
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Brief summary public domain (ClinicalTrials.gov)
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.
Intervention public domain (ClinicalTrials.gov)
Drug: 18F-DOPA. 18F-DOPA intravenous injection single dose
Arm public domain (ClinicalTrials.gov)
18F-DOPA scan (experimental): 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).
Primary outcome public domain (ClinicalTrials.gov)
Immediate safety evaluation. Clinical screen for adverse reactions to 18F-DOPA injection Time frame: Within 1 hour of injection.
Secondary outcome public domain (ClinicalTrials.gov)
Delayed safety evaluation. Time frame: 10-14 days after injection.
Secondary outcome public domain (ClinicalTrials.gov)
Delayed safety evaluation - referring physician. Time frame: 6 months after injection.
Secondary outcome public domain (ClinicalTrials.gov)
Biodistribution: scan interpreter will evaluate the distribution of tracer and comment if expected. Time frame: Within 3 days after injection.
Secondary outcome public domain (ClinicalTrials.gov)
Perceived clinical benefit. Time frame: 6 months after injection.
Eligibility public domain (ClinicalTrials.gov)
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
Enrollment public domain (ClinicalTrials.gov)
Enrollment: 400 participants (actual).