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ACTIVE NOT RECRUITING
NCT03697395
PHASE2

Advanced Immunoclinical Phenotyping of Rejection in Lung Transplant

Sponsor: University of Virginia

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

1200

Start Date

2019-04-01

Completion Date

2038-12-31

Last Updated

2024-11-18

Healthy Volunteers

No

Interventions

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)

Locations (1)

University of Virginia Health System

Charlottesville, Virginia, United States