Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-23
Brief Title:
In Vivo Study of Neuroinflammation in Tobaccosmoking a Clinical PET Study of TSPO Using 18FPBR111
Sponsor:
Prof Daniele Zullino
Organization:
University Hospital Geneva
Study Overview
Official Title:
In Vivo Study of Neuroinflammation in Tobaccosmoking a Clinical Positron EmissionTomography PET Study of 18 kDa TranslocatorProtein TSPO Using 18FPBR111 Part A
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
Tobacco smoking is associated with multiple and well-recognized adverse health effects However the direct effects of smoking on the brain are less well understood On of the mechanisms that could be associated with tobacco-related brain toxicity is neuroinflammation PETCT imaging constitutes an excellent means of assessment of neuroinflammation in vivo with the quantification of TSPO using 18FPBR111 Nonetheless this radiopharmaceutical has not been authorized for human use in Switzerland
Detailed Description:
Our study thus includes two parts Part A involves a dosimetry study ie measure the exposure of the body organs of healthy individuals to radioactivity after the administration of 200 MBq of 18FPBR111 This is a prerequisite for the authorization of the use of this radiotracer in humans Next the main part of this study part B involves the comparison of the quantity of TSPO in the brain of otherwise healthy smokers and age- and sex-matched non-smokers
Part A
Primary objective to establish the exposure of the organstissues to a standard radioactive dose 200 MBq of 18FPBR111
Part A
Primary objective to establish the exposure of the organstissues to a standard radioactive dose 200 MBq of 18FPBR111
Study Oversight
Has Oversight DMC:
None
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?:
None