Correlation of Lung Biopsy, BAL, and High Resolution CT Scan in Lung Transplantation

Bronchiolitis Obliterans Syndrome Clinical Trial

Official title:

Correlation of Lung Biopsy, BAL, and High Resolution CT Scan in Lung Transplantation. Can We Help Diagnose Acute Rejection and Better Predict Bronchiolitis Obliterans?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00528853
• Other study ID #: 15660A
• Status: Completed
• Phase: N/A
• First received: September 10, 2007
• Last updated: August 18, 2016
• Start date: August 2007
• Est. completion date: December 2009

Study information

• Verified date: August 2016
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

A major source of graft failure and dysfunction in lung transplantation is known to be bronchiolitis obliterans (BO)and its clinical correlate called bronchiolitis obliterans syndrome(BOS). In fact, BOS is the leading cause of death in lung recipients beyond one year post transplant. Currently, our ability to assess lung injury after transplant is less than ideal.

The purpose of this study is to use new computerized tomography(CT) technology, specifically , 64 bit acquisition, to detect and predict the onset of lung injuries, with the hope of finding better therapies that currently exist.

Description:

Total enrollment : 10

Lung transplant patients will undergo CT Scans before scheduled bronchoscopies which are routinely performed at 1, 3, 6, 9, and 12 months post transplant. Imaging will be done with the newest generation scanner, with intent to analyze all pertinent areas of the lung for pathology, but especially the bronchial anastomoses, the lung parenchyma with focus on gas exchanging lobules of the lung, and any suspected abnormalities from physical exam, laboratory tests, or prior chest xray.

CT imaging will precede bronchoscopy and biopsy so that CT interpretation will be unencumbered by changes due to the bronchoscopic procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Lung transplant patients who are at least 18 years of age.

• All patients must be able to give written informed consent.

Exclusion Criteria:

• Lung transplant patients who are unable to undergo a CT Scan.

• Lung transplant patients who are unable to give informed consent.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis Obliterans
• Bronchiolitis Obliterans Syndrome

Locations

Country	Name	City	State
United States	The University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States,