Imaging Inflammation With Alcohol Use Disorder: an [18F]NOS Study

Early Phase 1

Recruiting

• Conditions: Alcohol Use Disorder
• Interventions: Drug: [18F]NOS

• Registration Number: NCT05885594
• Lead Sponsor: University of Pennsylvania

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.

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 1-hour 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 Timeline

• Study Start: 2023-04-25
• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-06-02
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-23
• Primary Completion: 2027-03-15
• Study Completion: 2027-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HV-Healthy Volunteer	[18F]NOS	30 adult men and women between the ages of 18-65 who do not have alcohol use disorder and are a healthy volunteer will be enrolled in this study.
AUD-Alcohol Use Disorder	[18F]NOS	60 adult men and women who have alcohol use disorder will undergo up to 2 PET/CT scans each 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.

Primary Outcome Measures

Name	Time	Method
[18F]NOS uptake (distribution volume) in the brain and other organs in body	2 hours	The primary outcome measure to be analyzed is a comparisons of AUD subjects and healthy control subjects in the amount of \[18F\]NOS uptake (distribution volume) in brain and heart.

Secondary Outcome Measures

Name	Time	Method
Amount of c-reactive protein (mg/dl) in blood	1 hour	The secondary outcome measure is the comparison of AUD subjects and healthy control subjects in the amount of c-reactive protein in mg/dl, and its association with \[18F\]NOS uptake (distribution volume) in brain and other organs in body.
Amount of magnetic resonance spectroscopy Glutamate levels (in mM) in the brain	1 hour	The third outcome measure to be analyzed is the comparison of AUD subjects and healthy control subjects in brain Glutamate levels (in mM), and its association with \[18F\]NOS uptake (distribution volume) in brain.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States