Correlation of Lung Biopsy, BAL, and High Resolution CT Scan in Lung Transplantation - Full Text View

Sponsored by:	University of Chicago
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00528853

Purpose

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.

Condition
Bronchiolitis Obliterans Syndrome

MedlinePlus related topics: CT Scans Lung Transplantation Nuclear Scans

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
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?

Further study details as provided by University of Chicago:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	10
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2008

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Lung transplant patients meeting inclusion criteria will be recruited from the lung transplant clinic.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528853

Contacts

Contact: Tracy Valeroso, MSN, RN	773-834-0910	tvaleros@medicine.bsd.uchicago.edu
Contact: Lourdes Norwick, BSN, RN	773-834-8076	lnorwick@medicine.bsd.uchicago.edu

Locations

United States, Illinois
The University of Chicago Medical Center	Recruiting
Chicago, Illinois, United States, 60637
Principal Investigator: Edward Garrity, MD,
Sub-Investigator: Sangeeta Bhorade, MD

Sponsors and Collaborators

University of Chicago

Investigators

Principal Investigator:

Edward Garrity, MD

University of Chicago

More Information

Responsible Party:	University of Chicago ( Edward Garrity, MD )
Study ID Numbers:	15660A
Study First Received:	September 10, 2007
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00528853
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

Bronchiolitis Obliterans Syndrome

Study placed in the following topic categories:

Lung Diseases, Interstitial
Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases

Lung Diseases
Bronchiolitis
Bronchitis
Bronchiolitis Obliterans

Additional relevant MeSH terms:

Pathologic Processes
Disease
Bronchial Diseases
Syndrome

ClinicalTrials.gov processed this record on January 15, 2009