Advanced Immunoclinical Phenotyping of Rejection in Lung Transplant (NCT03697395) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Advanced Immunoclinical Phenotyping of Rejection in Lung Transplant
United States1,200 participantsStarted 2019-04-01
Plain-language summary
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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. All patients who successfully underwent lung transplant at the University of Virginia.
✓. Followed by medical lung transplant team for post-lung transplant rejection surveillance program at the University of Virginia.
✓. Subjects with co -morbid illnesses such as neurologic, liver and or kidney or GI tract disease/ dysfunction are not excluded
✓. Clinically stable to undergo MRI Imaging
Exclusion criteria
✕. Continuous oxygen use at home if decided to consent for MRI imaging
✕. Blood oxygen saturation of less than 92%as measured by pulse oximetry on the day of imaging if decided to consent for MRI imaging.
✕. Forced Expiratory Volume in 1 second (FEV1) percent predicted less than 25% if decided to consent for MRI imaging.
✕. Pregnancy or lactation if decided to consent for MRI imaging.
✕. 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.
✕. 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.
✕. History of congenital cardiac disease, chronic renal failure, or cirrhosis if decided to consent for MRI imaging.
What they're measuring
1
Successful collection of all samples as proposed.
Timeframe: 24 months after the date of lung transplant surgery