Optical Coherence Tomography of Airway and Pleural Disorders - Tabular View

Tracking Information

First Received Date ^ICMJE

December 20, 2007

Last Updated Date

March 13, 2009

Start Date ^ICMJE

July 2007

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00580892 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Optical Coherence Tomography of Airway and Pleural Disorders

Official Title ^ICMJE

Optical Coherence Tomography of Airway and Pleural Disorders

Brief Summary

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.

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case-Only, Prospective

Condition ^ICMJE

Endobronchial Disorder

Intervention ^ICMJE

Device: OCT

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

July 2012

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00580892

Responsible Party

Matthew Brenner, MD, Beckman Laser Institute

Study ID Numbers ^ICMJE

NIH OCT. EB-093-07, Phillip Morris, LAMMP MET RR-01192-29

Study Sponsor ^ICMJE

University of California, Irvine

Collaborators ^ICMJE

Pulmonary and Critical Care Medicine, UCI medical Center
Chao Family Comprehensive Cancer Center
Beckman Laser Institute University of California Irvine

Investigators ^ICMJE

Principal Investigator:

Matthew Brenner, M.D

Beckman Laser Institute

Information Provided By

University of California, Irvine

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP