Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2026-03-04 @ 11:10 PM
Study NCT ID:
NCT03042416
Status:
COMPLETED
Last Update Posted:
2022-01-10
First Post:
2017-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
Sponsor:
University of Alberta
Organization:
Study Overview
Official Title:
18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: