NCT05656105招募中1 期
PET Imaging of Neuroinflammation in Patients With Neurological Dysfunction After SARS-CoV-2 Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Measurement of regional brain TSPO levels using PET in participants with neurological PASC and healthy volunteers
研究概览
简要总结
This clinical imaging study will use the small molecule translocator protein (TSPO) ligand, Fluorodeoxyglucose(18F)-labeled DPA-714, to visualize and quantify neuroinflammation in individuals with post-acute sequelae of SARS-CoV-2 (PASC) . The brain uptake of DPA-714 will be contrasted with healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 65 years of age
- •Healthy volunteer OR Clinical diagnosis of post-acute sequelae of SARS-CoV-2 (PASC)
- •High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs
- •PASC participants must have been previously infected with SARS-CoV-
- •Their neurological symptoms must have been present for at least four weeks prior to the enrollment.
- •Healthy control participants must have no neurological symptoms
排除标准
- •Contraindication to MRI
- •Individuals who are unable to participate in the imaging portion due to severity of their medical condition
- •Chronic infectious disease (e.g. HIV, HCV)
- •Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation
- •Diagnosis of cancer, including leukemia
- •Blood or blood clotting disorder
- •Except for individuals with Multiple Sclerosis (MS), a diagnosis of autoimmune disease is exclusionary
- •Positive urine β-hCG test day of procedure or a serum human chorionic gonadotropin (hCG) test within 48 hours prior to the administration of [18F]DPA-714.
- •11Currently enrolled in a clinical trial utilizing experimental therapies.
- •Currently taking experimental therapies
- •Low affinity binder for TSPO ligands based on genotyping for SNP rs
- •The following exclusionary criteria apply only to PASC patients and healthy controls:
- •14. Self-reported history of moderate or severe traumatic brain injury
- •Self-reported history of whiplash injury
- •Self-reported history of Inflammatory bowel disease (IBD). (Individuals with Irritable Bowel Syndrome (IBS) and no signs of inflammation will be allowed to participate.)
- •The following blood test results (at screening) will be exclusionary:
- •Rheumatoid Factor (RF) => 14 IntUnits/mL,
- •Anti-nuclear antibody (ANA) > 1:80,
- •Erythrocyte sedimentation rate (ESR) > 60mm/hour, 21.High sensitivity C-reactive protein (hsCRP) > 10mg/L,
- •Complete blood count (CBC) results indicating acute infection, anemia, or other condition,
- •T3, T4, or thyroid-stimulating hormone (TSH) levels out of normal range,
- •Fasting glucose > 100 mg/dL,
- •Blood chemistry results indicating organ damage or other serious medical condition
- •Use of illicit substances within the past 6 months
- •Self-reported diagnosis of Type I or Type II diabetes
- •Healthy controls must not regularly take over-the-counter anti-inflammatory medication, analgesics (except aspirin), or sleep medication
研究组 & 干预措施
Healty Volunteers
Experimental
干预措施: DPA-714 PET/MRI (Drug)
PASC
Experimental
Patients meeting the case definition criteria for PASC
干预措施: DPA-714 PET/MRI (Drug)
结局指标
主要结局
Measurement of regional brain TSPO levels using PET in participants with neurological PASC and healthy volunteers
时间窗: Injection/scan date to clinical follow-up. (Usually within 6 weeks)
PET measures of TSPO binding in brain regions including cerebral cortex, thalami, and brainstem will be quantified in symptomatic study participants and healthy volunteers will be collected and compared between groups
次要结局
未报告次要终点
研究者
Deepak Prabataram Kalbi
Assistant Professor
University of Alabama at Birmingham
研究点 (2)
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