Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06098612
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-10-18
Brief Title:
PET Imaging Evaluation of 11CSY08
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
PET Imaging Evaluation of 11CSY08
Status:
RECRUITING
Status Verified Date:
2024-03
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:
The overall goal of the proposed research is to evaluate the use of 11CSY08 as a PET radiotracer for aggregated alpha synuclein αS in individuals with Parkinsons disease PD Multiple system atrophy MSA Dementia with Lewy Bodies DLB and healthy controls
The purpose of this study is to evaluate the use of 11CSY08 as a PET radiotracer for αS fibrils in individuals with PD MSA DLB and healthy controls The specific aims of the current study are
1 To determine brain uptake distribution and kinetics of 11CSY08 in healthy individuals
2 To determine brain uptake distribution and kinetics of 11CSY08 in patients with alpha synuclein aggregates in the brain including PD DLB and MSA
3 To determine human dosimetry of 11CSY08 in healthy individuals
An intravenous bolus injection of 11CSY08 will be administered per subject for brain PET imaging
The purpose of this study is to evaluate the use of 11CSY08 as a PET radiotracer for αS fibrils in individuals with PD MSA DLB and healthy controls The specific aims of the current study are
1 To determine brain uptake distribution and kinetics of 11CSY08 in healthy individuals
2 To determine brain uptake distribution and kinetics of 11CSY08 in patients with alpha synuclein aggregates in the brain including PD DLB and MSA
3 To determine human dosimetry of 11CSY08 in healthy individuals
An intravenous bolus injection of 11CSY08 will be administered per subject for brain PET imaging
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None