Critical Asymptomatic Carotid Artery Disease, Non-Critical Asymptomatic Carotid Artery Disease
Conditions
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 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.
Interventions
DRUG[18F]DPA-714
Investigational PET Tracer \[18F\]DPA-714
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total volume distribution of the regional time-activity curves from the TSPO- PET Data. | Pre-study to 48 hours post PET imaging. | 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. |
Contacts
PRINCIPAL_INVESTIGATORJonathan McConathy, MD,PhD
University of Alabama at Birmingham
Outcome results
None listed