Neuroinflammation in Asymptomatic Carotid Artery Disease - Imaging Substudy

Who is this study for? Patients with asymptomatic carotid artery disease
What treatments are being studied? [18F]DPA-714
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Cohort 1 - Critical Asymptomatic Carotid Stenosis Group Inclusion Criteria:

• 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 Inclusion Criteria:

• 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

Locations
United States
Alabama
UAB
RECRUITING
Birmingham
Contact Information
Primary
Evan Hudson
evanhudson@uabmc.edu
205-934-6499
Time Frame
Start Date: 2028-04-01
Estimated Completion Date: 2028-04
Participants
Target number of participants: 20
Treatments
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.
Experimental: Cohort 2 - Controls-Non-Critical Asymptomatic Carotid Stenosis Group
\<40% carotid stenosis No planned revascularization
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov