Neuroinflammation in Asymptomatic Carotid Artery Disease - Imaging Substudy

This clinical imaging substudy will use the small molecule translocator protein (TSPO) ligand, Fludeoxyglucose(18F)-labeled DPA-714, to compare neuroinflammation in individuals with high or low grade asymptomatic carotid artery stenosis (aCAD) who are participating in the separate Neuroinflammation in Asymptomatic Carotid Artery Disease study lead by Dr. Ron Lazar (IRB-300007806). The positron emission tomography (PET) tracer [18F]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation.

Study Overview

• Status: Withdrawn
• Conditions: Critical Asymptomatic Carotid Artery Disease; Non-Critical Asymptomatic Carotid Artery Disease
• Intervention / Treatment: Drug: [18F]DPA-714

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • UAB
      • Contact: Evan Hudson, BS; Phone Number: 205-934-6499; Email: evanhudson@uabmc.edu
      • Principal Investigator: Jonathan McConathy, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Cohort 1 - Critical Asymptomatic Carotid Stenosis Group Inclusion Criteria:

1. Critical Stenosis Group: Diagnosis of Asymptomatic Carotid Artery Disease (aCAD) with >70% stenosis or peak systolic velocity on DUS ≥ 230 cm/s plus CTA or MRA confirmation.
2. Participation in University of Alabama at Birmingham (UAB) IRB protocol "Neuroinflammation in Asymptomatic Carotid Artery Disease" (IRB-300007806, PI Lazar).
3. Male or female age >18 years
4. English speaking with at least 8th grade education
5. High affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971
6. Planned revascularization for aCAD in >14 days from time of consent

Cohort 2 - Non-Critical Asymptomatic Carotid Stenosis Group Inclusion Criteria:

1. Participation in UAB IRB protocol "Neuroinflammation in Asymptomatic Carotid Artery Disease" (IRB-300007806, PI Lazar).
2. <40% carotid stenosis
3. No planned revascularization
4. Male or female age 18 or older
5. English speaking with at least 8th grade education
6. High affinity binder for TSPO ligands based on genotyping SNP rs6971

Exclusion Criteria:

1. Contraindication to MRI
2. Pregnancy or lactation
3. Previous revascularization for treatment of aCAD
4. Prior stroke
5. Severe anemia (blood hemoglobin ≤ 8 mg/dL)
6. Previously obtained MRI scan with evidence of clinically significant abnormality
7. History of traumatic head injury defined by loss of consciousness >30 minutes or seizure at the time of the injury
8. Major depression
9. Known history of dementia
10. Serious medical comorbidity that, based on the judgement of the principal investigator, may interfere with study participation
11. Low or mixed-affinity binding for TSPO ligands based on genotyping for SNP rs6971.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 - Critical Asymptomatic Carotid Stenosis Group; Critical Stenosis Group: Diagnosis of Asymptomatic Carotid Artery Disease (aCAD) with >70% stenosis or peak systolic velocity on duplex ultrasound (DUS) ≥ 230 cm/s plus computed tomography angiography (CTA) or magnetic resonance angiography (MRA) confirmation.	Drug: [18F]DPA-714; Investigational PET Tracer [18F]DPA-714
Experimental: Cohort 2 - Controls-Non-Critical Asymptomatic Carotid Stenosis Group; <40% carotid stenosis No planned revascularization	Drug: [18F]DPA-714; Investigational PET Tracer [18F]DPA-714

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total volume distribution of the regional time-activity curves from the TSPO- PET Data.	The regional time-activity curves from the TSPO-PET data will be combined with image derived input function to provide estimates of total volume distribution (VT) based on a 2-tissue-compartment model (2-TCM) and graphical Logan plot analysis.	Pre-study to 48 hours post PET imaging.

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Jonathan McConathy, MD,PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2028
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Inflammation; Neuroinflammatory Diseases; Carotid Artery Diseases
• Other Study ID Numbers: IRB-300008773 R22-019; UAB (Other Identifier: UAB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No