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Optical Coherence Tomography of Airway and Pleural Disorders

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00580892
First received: December 20, 2007
Last updated: December 26, 2012
Last verified: December 2012
History of Changes
  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: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Optical Coherence Tomography of Airway and Pleural Disorders

Resource links provided by NLM:

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 ]

Estimated Enrollment: 150
Study Start Date: July 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
imaging
 Device: OCT
imaging

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
Beckman Laser Institute, UCI
Irvine, California, United States, 92612
Pulmonary and Critecal Care Medicine, UCI Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
Montana Compton
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: NCT00580892     History of Changes
Other Study ID Numbers: NIH OCT. EB-093-07
Study First Received: December 20, 2007
Last Updated: December 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Optical biopsy

Additional relevant MeSH terms:
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013