Optical Coherence Tomography of Airway and Pleural Disorders

This study is enrolling participants by invitation only.

First Received: December 20, 2007 Last Updated: March 13, 2009 History of Changes

Sponsor:	University of California, Irvine
Collaborators:	Pulmonary and Critical Care Medicine, UCI medical Center Chao Family Comprehensive Cancer Center Beckman Laser Institute University of California Irvine
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00580892

Purpose

Endobronchial disorders represent abnormal processes within the network of passages delivering air to the lung, including lung cancers. Pleural disorders involve the membrane that covers the lung and lines the inside of the chest walls.

Early detection of these disorders is essential to timely, accurate diagnosis and treatment of these conditions including cancer, inflammation and infections.

Condition	Intervention
Endobronchial Disorder	Device: OCT

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Optical Coherence Tomography of Airway and Pleural Disorders

Resource links provided by NLM:

MedlinePlus related topics: Pleural Disorders

U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

Screening aid in identification of suspect tissue lesion. [ Time Frame: 30 MINUTES ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	150
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1	Device: OCT Optical biopsy

Detailed Description:

Optical methods for obtaining images in airway passages for early detection of endobronchial lung and pleural cancer are needed. Optical coherence tomography (OCT) is a non-invasive or minimally invasive diagnostic technique that can provide information about tissue abnormalities.

OCT can produce images of abnormalities both at and below the surface of the airways without damaging the tissue surface This technique uses a harmless device to emit infrared (not visible) light that can produce images of the specimen under investigation without causing damage or alterations.

Eligibility

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

Study Population

primary care clinic

Criteria

Inclusion Criteria:

adult 18 or older, male or female.
require bronchoscopic with possible biopsy procedures.

Exclusion Criteria:

age less than 18 years of age
NO bronchoscopic with possible biopsy procedures.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580892

Locations

United States, California
Pulmonary and Critecal Care Medicine, UCI Medical Center
Orange, California, United States, 92868
Beckman Laser Institute, UCI
Irvine, California, United States, 92612

Sponsors and Collaborators

University of California, Irvine

Pulmonary and Critical Care Medicine, UCI medical Center

Chao Family Comprehensive Cancer Center

Beckman Laser Institute University of California Irvine

Investigators

Principal Investigator:

Matthew Brenner, M.D

Beckman Laser Institute

More Information

No publications provided

Responsible Party:	Beckman Laser Institute ( Matthew Brenner, MD )
Study ID Numbers:	NIH OCT. EB-093-07, Phillip Morris, LAMMP MET RR-01192-29
Study First Received:	December 20, 2007
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00580892 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

Optical biopsy

Additional relevant MeSH terms:

Pathologic Processes
Disease
Respiratory Tract Diseases
Pleural Diseases

ClinicalTrials.gov processed this record on November 27, 2009