18F-αvβ6-binding-peptide PET/CT in Patients Post SARS CoV2 Infection
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Administration of 18F-αvβ6-BP
研究概览
简要总结
This is a PET/CT study using the 18F-αvβ6-binding-peptide.The goal of this study is to evaluate this peptide in patients after infection with SARS CoV2.
详细描述
The goal of the study is to to acquire 18F-αvβ6-BP PET/CT images in patients diagnosed with SARS CoV2 and to demonstrate the ability of 18F-αvβ6-BP to detect lung damage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women age ≥ 18 yrs
- •Diagnosed with SARS CoV2
- •Must have 2 sequential COVID negative tests prior to each scan
- •Must have no previous lung disease prior to SARS CoV2 infection
- •Lung image (Xray or CT) taken during infectious/ diagnosis period
- •Will sign the IRB-approved consent form
- •Able to remain motionless for up to 30-60 minutes per scan.
排除标准
- •Life expectancy <3 mo
- •Women who are pregnant or breast-feeding
- •Patients who cannot undergo PET/CT scanning because of weight limits(>350lbs)
- •Lack of availability for follow-up assessments
- •Re-infection with SARS CoV2 between scan sessions
- •Other active infectious respiratory illness
研究组 & 干预措施
18F-αvβ6-BP
Following a 10 mCi (±20%) intravenous injection (IV) of 18F-αvβ6-BP, PET/CT images will be acquired at 60 minutes. Baseline blood samples will be drawn and banked. Vital sign (VS) measurements (heart rate, respiratory rate, blood pressure and temperature) monitored throughout. Region-of-interest analysis (ROI) will be performed in the lung. Each participant will undergo up to 3 18F- αvβ6-BP PET/CT scans over a 6-month timeframe.
干预措施: 18F-αvβ6-BP (Drug)
结局指标
主要结局
Administration of 18F-αvβ6-BP
时间窗: 6 months
Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients
Administration of 18F-αvβ6-BP
时间窗: baseline
Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients
Administration of 18F-αvβ6-BP
时间窗: 3 months
Completion of administration of 18F-αvβ6-BP in SARC CoV2 patients
次要结局
- Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage(6 months)
- Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage(baseline)
- Determine whether 18F-αvβ6-BP demonstrates accumulation in lung damage(3 months)