Positron Emission Tomography Assessment of Acute Lung Transplant Rejection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Ki, the influx constant that describes the rate of [18F]FDG uptake, in the whole lung
研究概览
简要总结
The purpose of this research study is to gain understanding of the basic responses of the lungs to inflammation and specifically if there may be a better way to detect graft inflammation using non-invasive methods as well as to determine the effectiveness of immunosuppressive treatment regimens in preventing acute rejection in lung transplant recipients.
详细描述
Positron emission tomography with fluorodeoxyglucose (FDG-PET) is a potential way we can measure lung inflammation. FDG-PET imaging is a clinically accepted and FDA-approved method that is commonly used in the diagnosis and management of cancer. PET is a machine that detects radiation and generates pictures using a donut shaped scanner similar in appearance to an x-ray "CAT" computerized axial tomography or computed tomography (CT) scan. FDG stands for [18F] (flourine 18) fluorodeoxyglucose, a radiolabeled sugar that is used to identify areas of inflammation with the PET scanner. A CT scan takes a picture of what the lungs and airways look like.
T cells are the primary cause of acute rejection of lung transplants. Because T cells must divide in order to be activated and cause rejection, imaging them while they are dividing is another way that we can determine whether acute rejection is occurring. A new PET tracer called [18F]ISO-1 (18F-labeled σ2-receptor ligand for PET, N-(4-(6,7-dimethoxy-3,-4-dihydroisoquinolin-2(1H)-yl)butyl)-2-(2-18F-fluoroethoxy)-5-methylbenzamide (18F-3c), binds to dividing cells. Therefore, [18F]ISO-1 may help us measure acute rejection more accurately. [18F]ISO-1 is an investigational drug.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Double-lung transplant recipient
- •Scheduled for bronchoscopy with transbronchial biopsy
- •Capable of lying still and supine with arms raised above the head within the PET/CT scanner for ~1.25 hours
- •Capable of following instructions for breathing protocol during CT portion of PET/CT
- •Able and willing to give informed consent
- •BMI < 35
- •Already scheduled to undergo bronchoscopy with bronchoalveolar lavage (BAL) for clinical reasons
- •Willing to donate a portion of BAL and biopsy specimen for laboratory testing
排除标准
- •Glucose level > 150 mg/dl at time of [18F]FDG PET scan (however, up to 160 mg/dl, with repeat testing showing level is stable or decreasing, is acceptable)
- •Pregnancy (confirmed by qualitative urine human chorionic gonadotropin (hCG) pregnancy test)
- •Lactation
- •Presence of implanted electronic medical device
- •Enrollment in another research study of an investigational drug
- •Inability to lie flat with arms raised above the head for 1.5 hours for PET/CT scans or follow breathing protocol instructions for the CT portion of the PET/CT
研究组 & 干预措施
Grade A0
Double-lung transplant recipients with no evidence of rejection who undergo both [18F]FDG and [18F]ISO-1 PET imaging scans
干预措施: [18F]FDG (Drug)
Grade A0
Double-lung transplant recipients with no evidence of rejection who undergo both [18F]FDG and [18F]ISO-1 PET imaging scans
干预措施: [18F]ISO-1 (Drug)
Grades A2-3
Double-lung transplant recipients with mild to moderate rejection who undergo both [18F]FDG and [18F]ISO-1 PET imaging scans
干预措施: [18F]FDG (Drug)
Grades A2-3
Double-lung transplant recipients with mild to moderate rejection who undergo both [18F]FDG and [18F]ISO-1 PET imaging scans
干预措施: [18F]ISO-1 (Drug)
结局指标
主要结局
Ki, the influx constant that describes the rate of [18F]FDG uptake, in the whole lung
时间窗: This outcome measure is assessed from the [18F]FDG scan performed on Day 1.
Logan plot analysis determined distribution volume ratio (DVR) of [18F] ISO-1 uptake
时间窗: This outcome measure is assessed from the [18F]ISO-1 PET scan performed on Day 2.
次要结局
- Progesterone receptor membrane component 1 (PGRMC1) staining of biopsy tissues and bronchoalveolar lavage cells(Assessed after the baseline clinical bronchoscopy procedure is performed 3 days prior to FDG PET/CT scan)