Immunoclinical Phenotyping for Lung Transplant Rejection

Overseen By Roselove Asare

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Virginia

Disqualifiers: Continuous oxygen use, Pregnancy, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

1200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Yun M Shim, MD

Principal Investigator

University of Virginia

Eligibility Criteria

This trial is for patients who have had a lung transplant at the University of Virginia and are part of their post-transplant rejection surveillance program. Participants must be clinically stable for MRI imaging, and those with additional illnesses like neurological or kidney diseases can join. However, individuals with certain conditions such as congenital heart disease, severe renal failure, large chest circumference, dependence on continuous oxygen, very low blood oxygen levels or lung function, claustrophobia, incompatible implants or devices for MRI scanning cannot participate.

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

I am healthy enough to have an MRI scan.

Exclusion Criteria

I have a history of heart attack, stroke, or high blood pressure and agree to an MRI.

I can understand simple instructions and stay still for short periods.

I agree to MRI imaging despite having a heart condition, kidney failure, or cirrhosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Registry Formation and Tissue Banking

Participants undergo routine surveillance bronchoscopy and extra tissue sampling of blood and urine for registry formation and tissue banking

24 months

Regular visits for surveillance bronchoscopy

Imaging and Phenotyping

Subgroup of patients characterized by hyper polarized gas MRI to enhance detection of CLAD and correlate imaging results with clinical/biochemical results

Concurrent with registry formation

Follow-up

Participants are monitored for safety and effectiveness after registry formation and imaging

6 months

Treatment Details

Trial Overview The study aims to create a registry while collecting tissue samples from bronchoscopy procedures along with blood and urine samples. It will use clinical phenotyping and advanced imaging techniques to better understand chronic allograft rejection (CLAD) in lung transplant recipients.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+