OCT for Early Detection and Staging of Endobronchial Lung and Pleural Cancer, Airway Injury, and Prostate Cancer

This study is enrolling participants by invitation only.

First Received on December 19, 2007. Last Updated on October 28, 2011 History of Changes

Sponsor:	Montana Compton
Collaborators:	Beckman Laser Institute University of California Irvine Chao Family Comprehensive Cancer Center Pulmonary and Critical Care Medicine,University of California, Irvine University of California, Irvine
Information provided by (Responsible Party):	Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00581503

Purpose

Optic 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 diagnostic technique that can provide information about tissue abnormalities. This technique uses a near-infrared diode to emit light that can produce images of the specimen under investigation without causing damage or alterations.

Condition	Intervention
Lung Cancer Pleural Cancer Prostate Cancer	Device: diagnostic

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Optical Coherence Tomography for Early Detection and Staging of Endobronchial Lung and Pleural Cancer, Airway Injury, and Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Prostate Cancer

U.S. FDA Resources

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

Primary Outcome Measures:

the OCT results are at least as accurate as the standard Pathology results. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	March 2007
Estimated Study Completion Date:	July 2015
Estimated Primary Completion Date:	July 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
diagnostic oct imaging	Device: diagnostic oct imaging

Detailed Description:

Optical coherence tomography (OCT) is a non-invasive diagnostic technique that can provide information about tissue abnormalities. This technique uses a near-infrared diode to emit light that can produce images of the specimen under investigation without causing damage or alterations.

The research' want to compare the OCT results with that obtained from conventional histologic examination and to show that the OCT results may be almost as accurate as the standard Pathology results.

Optical coherence tomography (OCT) is a new technique being developed that can be used for visualizing human tissue. OCT offers a means of providing information on the characteristics and extent of a lesion (and abnormal change in structure of an organ).

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 years and older
Having procedure of endobronchial, transbronchial, and / or pleural biopsy

Exclusion Criteria:

Currently participating in any other investigational drug or device evaluation.
Currently taking drugs that are sensitive to light.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581503

Locations

United States, California
Beckman Laser Institute,University of California, Irvine
Irvine, California, United States, 92612
Pulmonary and Critical Care Medicine, UCI Medical Center
Orange, California, United States, 92868
Urology department, UCI Medical Center
Orange, California, United States, 92868

Sponsors and Collaborators

Montana Compton

Beckman Laser Institute University of California Irvine

Chao Family Comprehensive Cancer Center

Pulmonary and Critical Care Medicine,University of California, Irvine

University of California, Irvine

Investigators

Principal Investigator:

Matthew Brenner, M.D

Beckman Laser Institute

More Information

No publications provided

Responsible Party:	Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00581503 History of Changes
Other Study ID Numbers:	NIH OCT-EB-02493-07
Study First Received:	December 19, 2007
Last Updated:	October 28, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

early detection of lung and pleural cancer
early detection of prostate cancer

Additional relevant MeSH terms:

Lung Neoplasms
Prostatic Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms

Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012