Neuroinflammation in Asymptomatic Carotid Artery Disease - Imaging Substudy
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Total volume distribution of the regional time-activity curves from the TSPO- PET Data.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: [18F]DPA-714 (Drug)
Cohort 2 - Controls-Non-Critical Asymptomatic Carotid Stenosis Group
<40% carotid stenosis No planned revascularization
干预措施: [18F]DPA-714 (Drug)
结局指标
主要结局
Total volume distribution of the regional time-activity curves from the TSPO- PET Data.
时间窗: 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.
次要结局
未报告次要终点
研究者
Jonathan E McConathy
Official Title: M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics Affiliation: University of Alabama at Birmingham
University of Alabama at Birmingham