Status:
RECRUITING
Neuroinflammation in Asymptomatic Carotid Artery Disease - Imaging Substudy
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Critical Asymptomatic Carotid Artery Disease
Non-Critical Asymptomatic Carotid Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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 DUS ≥ 230 cm/s plus CTA or MRA confirmation.
- Participation in University of Alabama at Birmingham (UAB) IRB protocol "Neuroinflammation in Asymptomatic Carotid Artery Disease" (IRB-300007806, PI Lazar).
- Male or female age \>18 years
- English speaking with at least 8th grade education
- High affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971
- Planned revascularization for aCAD in \>14 days from time of consent
- Cohort 2 - Non-Critical Asymptomatic Carotid Stenosis Group
- Participation in UAB IRB protocol "Neuroinflammation in Asymptomatic Carotid Artery Disease" (IRB-300007806, PI Lazar).
- \<40% carotid stenosis
- No planned revascularization
- Male or female age 18 or older
- English speaking with at least 8th grade education
- High affinity binder for TSPO ligands based on genotyping SNP rs6971
Exclusion
- Contraindication to MRI
- Pregnancy or lactation
- Previous revascularization for treatment of aCAD
- Prior stroke
- Severe anemia (blood hemoglobin ≤ 8 mg/dL)
- Previously obtained MRI scan with evidence of clinically significant abnormality
- History of traumatic head injury defined by loss of consciousness \>30 minutes or seizure at the time of the injury
- Major depression
- Known history of dementia
- Serious medical comorbidity that, based on the judgement of the principal investigator, may interfere with study participation
- Low or mixed-affinity binding for TSPO ligands based on genotyping for SNP rs6971.
Key Trial Info
Start Date :
April 1 2028
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05238961
Start Date
April 1 2028
End Date
April 1 2028
Last Update
December 11 2025
Active Locations (1)
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1
UAB
Birmingham, Alabama, United States, 35294