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.
Sponsor:
Information provided by (Responsible Party):
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00581503
First received: December 19, 2007
Last updated: December 9, 2013
Last verified: December 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of California, Irvine
Investigators
Principal Investigator: Matthew Brenner, M.D Beckman Laser Institute
  More Information

No publications provided

Responsible Party: 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: December 9, 2013
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:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on October 16, 2014