Validation of MRI, CT and Pulmonary Function Tests for Early Detection of Chronic Lung Allograft Dysfunction
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Forced expiratory volume in 1 second (FEV1) Decline
研究概览
简要总结
This studies purpose is to confirm the efficacy and efficiency of using OE-MRI and MRI with hyperpolarized gas techniques and Iodinated contrast CT scan, this will enhance understanding of CLAD pathophysiology. Moreover, this project is foundational to performing additional studies to establish if novel MRI imaging can serve as an objective confirmatory diagnostic tool for CLAD in post-transplant patients.
详细描述
This studies purpose is to confirm the efficacy and efficiency of using OE-MRI and MRI with hyperpolarized gas techniques and Iodinated contrast CT scan, this will enhance understanding of CLAD pathophysiology. Moreover, this project is foundational to performing additional studies to establish if novel MRI imaging can serve as an objective confirmatory diagnostic tool for CLAD in post-transplant patients.
This observational imaging study will use 3T UTE MRI with varying oxygen levels (room air vs. 100% oxygen) to evaluate lung ventilation using oxygen enhanced imaging, in 50 healthy normal subjects (age 18-80).
Subjects will have vital signs taken, complete questionnaires and have pulmonary function test (spirometry) done, Iodinated contrast CT scan and standard of care CT scans, in addition to one MRI session that will include 6 series of scans. The MRI scans will be taken in supine position (laying on back) and include breathing room air and 100% oxygen. OE-MRI will be done in addition to MRI scans with Xenon-129.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects-Inclusion Criteria:
- •Ages 18-80
- •English Speaking Subjects
- •Willingness and ability to provide informed consent
- •Non-smoker
- •Lung transplant patients-inclusion criteria:
- •>/= 6 months from lung transplant
- •History of bilateral lung transplant
- •CLAD-free patients-inclusion criteria:
- •Stable spirometry with FEV1 > 90% of baseline value (average of 2 best values) and forced mid-expiratory flow (FEF) (25-75) > 75% of baseline
- •Total Lung Capacity (TLC) > 90 % of baseline
- •Post-transplant chest radiograph without significant abnormality
- •No evidence of on-going lung infection or allograft rejection
- •Early CLAD patients-inclusion criteria:
- •FEV1 < 80% of baseline value (average of 2 best values)
- •Follow up 6-months or decline in lung function (20% decrease in FEV1 without evidence of infection or acute rejection)
排除标准
- •SAO2 drops below 90% (in absence of mechanical failure) during normal tidal breathing
- •Unilateral diaphragm paralysis
- •Evidence of acute illness on day of study
- •Evidence of restrictive lung disease
- •Dependence on supplemental oxygen
- •History of cardiac disease
- •Pregnancy (self-declared)
- •Lactating women
- •Participants with metal objects in their body
- •Known contraindication to MRI examination
- •Systolic blood pressure reading of < 100 mmHg or > 200 mmHg
- •Diastolic blood pressure reading of <60 mmHg or > 100 mmHg
研究组 & 干预措施
Healthy Normal Subjects
Healthy subjects, with no lung diagnosis, who are non-smokers.
干预措施: Contrast Lung Computed Tomography (CT) Scan (Diagnostic Test)
Healthy Normal Subjects
Healthy subjects, with no lung diagnosis, who are non-smokers.
干预措施: Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan (Diagnostic Test)
Healthy Normal Subjects
Healthy subjects, with no lung diagnosis, who are non-smokers.
干预措施: 129Xe MRI scans (Drug)
Post Lung Transplant with normal functioning
Subjects who have had a lung transplant and now have normal lung function
干预措施: Spirometry (Diagnostic Test)
Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD)
Subjects who have had a lung transplant that now have CLAD
干预措施: Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan (Diagnostic Test)
Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD)
Subjects who have had a lung transplant that now have CLAD
干预措施: 129Xe MRI scans (Drug)
Post Lung Transplant with normal functioning
Subjects who have had a lung transplant and now have normal lung function
干预措施: Contrast Lung Computed Tomography (CT) Scan (Diagnostic Test)
Healthy Normal Subjects
Healthy subjects, with no lung diagnosis, who are non-smokers.
干预措施: Spirometry (Diagnostic Test)
Post Lung Transplant with normal functioning
Subjects who have had a lung transplant and now have normal lung function
干预措施: Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan (Diagnostic Test)
Post Lung Transplant with normal functioning
Subjects who have had a lung transplant and now have normal lung function
干预措施: 129Xe MRI scans (Drug)
Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD)
Subjects who have had a lung transplant that now have CLAD
干预措施: Spirometry (Diagnostic Test)
Post Lung Transplant with Chronic Lung Allograft Dysfunction (CLAD)
Subjects who have had a lung transplant that now have CLAD
干预措施: Contrast Lung Computed Tomography (CT) Scan (Diagnostic Test)
结局指标
主要结局
Forced expiratory volume in 1 second (FEV1) Decline
时间窗: Baseline and 3 months
Absolute decrease of FEV1 by 20%
次要结局
未报告次要终点
研究者
Sean Fain
Professor
University of Iowa