Advanced Immunoclinical Phenotyping of Rejection in Lung Transplant

赞助:

合作者:

信息的提供 (责任方):

Y. Michael Shim, MD，University of Virginia

追踪信息

首次提交日期 ^ICMJE

October 3, 2018

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

December 1, 2018

预计主要完成日期

December 31, 2028 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Successful collection of all samples as proposed.[ Time Frame: 24 months after the date of lung transplant surgery ]

Completion of surveillance bronchoscopy and other tissue collection at planned surveillance (24 months after the date of lung transplant surgery)

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

[ Time Frame: ]

描述性信息

简略标题 ^ICMJE

Advanced Immunoclinical Phenotyping of Rejection in Lung Transplant

正式标题 ^ICMJE

Advanced Immunoclinical Phenotyping of Rejection in Lung Transplant

简要概况

Chronic allograft rejection of the transplanted lung (CLAD) is a major health issue in patients after lung transplant. This study is a registry-forming study with concurrent tissue banking from surveillance bronchoscopy in addition to extra tissue sampling of blood and urine. Patients will be characterized by usual clinical phenotyping and the latest imaging methods so that diseased condition underlying CLAD can be better understood.

详细说明

Chronic allograft rejection of the transplanted lung (CLAD) is a major health issue that lead to almost 50% mortality within 5 years from the time of lung transplant. In the past CLAD was exclusively occurring in small airways causing a condition called "Bronchiolitis Obliteran Syndrome" (BOS). However, recently many have observed restrictive changes in lung physiology with or without parenchymal abnormalities. This new CLAD is called RAS or RCLAD. What is also concerning is that RAS is thought to be associated with disproportionally high morbidity and mortality. This clinical trial intends to create a registry of patients who completed lung transplant and who are undergoing routine surveillance bronchoscopy. A subgroup of patients will be characterized by hyper polarized gas magnetic resonance image to enhance detection of CLAD, and to be correlated between the MRI imaging results and clinical/biochemical results. This study is anticipated to advance our understanding of CLAD which is currently inevitably fatal outcome among patients after lung transplant.

研究类型 ^ICMJE

Observational

研究阶段

研究设计 ^ICMJE

分配:
干预模型:
干预模型描述:
盲法: Observational
盲法描述:
主要目的:

适用条件 ^ICMJE

干预项目 ^ICMJE

Diagnostic Test: Lung transplant recipient without MRI imaging
Patients who received lung transplant and undergoing surveillance follow-up at 1, 3, 6, 12, 24 months after the date of lung transplant, but without consenting to be evaluated by hyperbolized gas MRI. Bronchoscopy sampling will be performed per usual lung transplant team protocol.
Drug: Lung transplant recipient with MRI imaging
Patients who received lung transplant and undergoing surveillance follow-up at 1, 3, 6, 12, 24 months after the date of lung transplant and with consenting to be evaluated by hyperbolized has MRI. Bronchoscopy sampling will be guided by the results of the hyper polarized gas MRI, different from the usual lung transplant team protocol. Administration of hyper polarized gas MRI is under FDA regulation by IND #129769 (PI, Yun Michael Shim, MD)

研究工具

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

1200

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

December 31, 2038

预计主要完成日期

December 31, 2028 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: 1. All patients who successfully underwent lung transplant at the University of Virginia. 2. Followed by medical lung transplant team for post-lung transplant rejection surveillance program at the University of Virginia. 3. Subjects with co -morbid illnesses such as neurologic, liver and or kidney or GI tract disease/ dysfunction are not excluded 4. Clinically stable to undergo MRI Imaging Exclusion Criteria: 1. Continuous oxygen use at home if decided to consent for MRI imaging 2. Blood oxygen saturation of less than 92%as measured by pulse oximetry on the day of imaging if decided to consent for MRI imaging. 3. Forced Expiratory Volume in 1 second (FEV1) percent predicted less than 25% if decided to consent for MRI imaging. 4. Pregnancy or lactation if decided to consent for MRI imaging. 5. Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning. Subjects with any implanted device that cannot be verified as MRI compliant will be excluded if decided to consent for MRI imaging. 6. Chest circumference greater than that of the xenon MR and/or helium coil. The circumference of the coil is approximately 42 inches if decided to consent for MRI imaging. 7. History of congenital cardiac disease, chronic renal failure, or cirrhosis if decided to consent for MRI imaging. 8. Inability to understand simple instructions or to hold still for approximately 10 seconds if decided to consent for MRI imaging. 9. History of respiratory infection within 2 weeks prior to the MR scan if decided to consent for MRI imaging. 10. History of MI, stroke and/or poorly controlled hypertension if decided to consent for MRI imaging.

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：83 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

United States

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: Yes
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Y. Michael Shim, MD，University of Virginia

研究赞助商 ^ICMJE

University of Virginia

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Yun M Shim, MD University of Virginia

PRS 账户

University of Virginia

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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