Parkinson Disease Clinical Trial
Official title:
18F-DOPA II - PET Imaging Optimization
A single centre non-randomized, non-blinded phase III prospective cohort study of 18F-DOPA PET/CT imaging in specific patient populations: 1. Pediatric patients (less than 18 years old) with congenital hyperinsulinism. 2. Pediatric patients (less than 18 years old) with neuroblastoma. 3. Pediatric (less than 18 years old) or Adult patients (18 or older) with known or clinically suspected neuroendocrine tumor. 4. Adult patients (18 or older) with a clinical suspicion of Parkinson's disease or Lewy body dementia. 5. Pediatric (less than 18 years old) or Adult patients (18 or older) with brain tumors. Image optimization (the primary study objective) and gallbladder activity pattern (the secondary objective) will be evaluated.
Status | Recruiting |
Enrollment | 800 |
Est. completion date | July 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Pediatric patients (less than 18 years old) with congenital hyperinsulinism. 2. Pediatric patients (less than 18 years old) with neuroblastoma. 3. Pediatric (less than 18 years old) or Adult patients (18 or older) with known or clinically suspected neuroendocrine tumor. 4. Adult patients (18 or older) with a clinical suspicion of Parkinson's disease or Lewy body dementia. 5. Pediatric (less than 18 years old) or Adult patients (18 or older) with brain tumors. Exclusion Criteria: 1. Unable to obtain consent 2. Weight >225 kg (weight limitation of PET/CT scanner) 3. Adult patients unable to lie flat for 20-30 minutes to complete the PET-CT session. 4. Young pediatric patients (less than 13 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). 5. Lack of intravenous access 6. History of previous cholecystectomy (excluded from dynamic abdomen sub-study only) 7. Pregnancy |
Country | Name | City | State |
---|---|---|---|
Canada | WC Mackenzie Health Science Centre / University of Alberta Hospital | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Minimum lesion detectibility (size) | Measurement of size (mm) of the three smallest lesions | Within 1 month of PET/CT scan | |
Primary | Assessment of bladder activity | Measurement of standardized uptake value (SUV) for urinary bladder activity | Within 1 month of PET/CT scan | |
Primary | Assessment of bladder activity artifact | Subjective scoring (0-2 scale) of image artifact in pelvis related to bladder activity | Within 1 month of PET/CT scan | |
Primary | Minimum lesion detectability (SUV) | Measurement of the standardized uptake value (SUV) of the three smallest lesions | Within 1 month of PET/CT scan | |
Secondary | Gallbladder activity pattern | Assessment of SUVmax of various segments of the biliary tree at different time points after 18F-DOPA injection using a subgroup of participants (64 total) | Within 3 months of PET/CT scan | |
Secondary | Gallbladder disease questionnaire | All participants will complete a questionnaire regarding a history of gallbladder disease | At the time of enrollment |
Status | Clinical Trial | Phase | |
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