Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 11:49 PM
Study NCT ID:
NCT05885594
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-26
First Post:
2023-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imaging Inflammation With Alcohol Use Disorder: an [18F]NOS Study
Sponsor:
University of Pennsylvania
Organization:
Study Overview
Official Title:
Imaging Inflammation in Individuals With Alcohol Use Disorder: an [18F]NOS Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
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:
AUD
Brief Summary:
Study to enroll up to 90 individuals, those with an alcohol use disorder (AUD) (up to n=60) and non-dependent healthy volunteers (HV) (up to n=30).
PET/CT imaging will be used to evaluate brain and whole-body inflammation using the investigational radiotracer \[18F\]NOS.
All participants will have one \[18F\]NOS positron emission tomography/ computed tomography (PET/CT) scan performed.
PET/CT imaging will be used to evaluate brain and whole-body inflammation using the investigational radiotracer \[18F\]NOS.
All participants will have one \[18F\]NOS positron emission tomography/ computed tomography (PET/CT) scan performed.
Detailed Description:
The Investigators plan to enroll up to 90 individuals in this study, which will enroll individuals with an alcohol use disorder (AUD) (up to n=60) and non-dependent healthy volunteers (HV) (up to n=30).
PET/CT imaging will be used to evaluate brain and whole-body inflammation using the investigational radiotracer \[18F\]NOS. All participants will have one \[18F\]NOS positron emission tomography/computed tomography (PET/CT) scan performed, unless this has been performed as part of another study. AUD participants enrolled in a companion treatment study #851593 "A Randomized, Double-blind Placebo-Controlled Study of Ibudilast for Treating Alcohol Use Disorder" will be asked to undergo a second \[18F\]NOS PET scan after the initiation of the study treatment.
For each PET/CT scan, patients will undergo approximately 60 minutes of dynamic scanning starting at the time of injection of \[18F\]NOS. PET/CT imaging sessions will include an injection of ≤ 6.5 mCi (approximate range for most studies is anticipated to be 3.5-6.5 mCi) of \[18F\]NOS. Data will be collected to evaluate uptake of \[18F\]NOS in the brain and other organs (e.g., lungs, heart, and liver), and measurements will be compared between groups.
Each participant will undergo a 90 minute brain MRI to measure brain inflammatory markers using GluCEST and spectroscopic imaging, unless this has been performed as part of another study and deemed acceptable by an investigator. On the PET day, a blood sample will be collected to measure established peripheral inflammatory biomarkers to be correlated with \[18F\]NOS uptake. AUD participants who are enrolled in the companion treatment study will be asked to undergo a second brain MRI, PET/CT scan, and blood draw for inflammatory markers after the initiation of treatment.
PET/CT imaging will be used to evaluate brain and whole-body inflammation using the investigational radiotracer \[18F\]NOS. All participants will have one \[18F\]NOS positron emission tomography/computed tomography (PET/CT) scan performed, unless this has been performed as part of another study. AUD participants enrolled in a companion treatment study #851593 "A Randomized, Double-blind Placebo-Controlled Study of Ibudilast for Treating Alcohol Use Disorder" will be asked to undergo a second \[18F\]NOS PET scan after the initiation of the study treatment.
For each PET/CT scan, patients will undergo approximately 60 minutes of dynamic scanning starting at the time of injection of \[18F\]NOS. PET/CT imaging sessions will include an injection of ≤ 6.5 mCi (approximate range for most studies is anticipated to be 3.5-6.5 mCi) of \[18F\]NOS. Data will be collected to evaluate uptake of \[18F\]NOS in the brain and other organs (e.g., lungs, heart, and liver), and measurements will be compared between groups.
Each participant will undergo a 90 minute brain MRI to measure brain inflammatory markers using GluCEST and spectroscopic imaging, unless this has been performed as part of another study and deemed acceptable by an investigator. On the PET day, a blood sample will be collected to measure established peripheral inflammatory biomarkers to be correlated with \[18F\]NOS uptake. AUD participants who are enrolled in the companion treatment study will be asked to undergo a second brain MRI, PET/CT scan, and blood draw for inflammatory markers after the initiation of treatment.
Study Oversight
Has Oversight DMC:
False
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?: