Neuroinflammation in Asymptomatic Carotid Artery Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2028-04-01

Study Completion Date

2028-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Critical Asymptomatic Carotid Artery Disease Non-Critical Asymptomatic Carotid Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

[18F]DPA-714

Intervention Type DRUG

Investigational PET Tracer \[18F\]DPA-714

Cohort 2 - Controls-Non-Critical Asymptomatic Carotid Stenosis Group

\<40% carotid stenosis No planned revascularization

Group Type EXPERIMENTAL

[18F]DPA-714

Intervention Type DRUG

Investigational PET Tracer \[18F\]DPA-714

Interventions

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[18F]DPA-714

Investigational PET Tracer \[18F\]DPA-714

Intervention Type DRUG

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No