Comparison Trial of White Light, Autofluorescence and Narrow Band Imaging Bronchoscopy (NWA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Maimonides Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Maimonides Medical Center
ClinicalTrials.gov Identifier:
NCT00548730
First received: October 22, 2007
Last updated: February 6, 2009
Last verified: January 2009
  Purpose

The purpose of the study is to compare the three methods of bronchoscopic imaging to determine what combination is optimum to identify neoplastic mucosal abnormalities. The ability to decrease the rate of false-positive and false negative findings of bronchoscopy also will be studied for each spectroscopic technique separately and for their combination.


Condition Intervention
Lung Cancer
Procedure: Bronchoscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinical Comparison Trial of White Light Bronchoscopy, Autofluorescence Bronchoscopy and Narrow Band Imaged Bronchoscopy

Resource links provided by NLM:


Further study details as provided by Maimonides Medical Center:

Primary Outcome Measures:
  • Degree of correlation between three different bronchoscopic images [ Time Frame: One day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Elimination of false positives and negative bronchoscopic examinations for neoplasia [ Time Frame: One day ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Endobronchial biopsies of normal and abnormal mucosa for histopathology


Estimated Enrollment: 100
Study Start Date: October 2007
Estimated Study Completion Date: December 2010
Groups/Cohorts Assigned Interventions
Observation
Patients with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy
Procedure: Bronchoscopy
The endoscopic examination of the bronchial tree will be performed using a commercially available flexible fluorescence bronchoscope and the flexible white light video-bronchoscope. Biopsies are taken of a normal region and all abnormal regions.
Other Names:
  • AF bronchoscope (11004BI)
  • NBI bronchoscope (BF-T180)

Detailed Description:

Patients with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy will be invited to participate in the study. All patients must be over 18 years old and must sign informed consent. The endoscopic examination of the bronchial tree will be performed using a commercially available flexible fluorescence bronchoscope (11004BI; Karl Storz; Culver City, CA) and the flexible white light video-bronchoscope (BF-T180; Olympus; Center Valley, PA).

Images obtained will be photographed using both video recordings and parallel images of white light and imaged bronchoscopy. These digital images will be electronically stored and evaluated at a later time. Biopsies will be obtained of all suspected abnormalities. These will be correlated with the images.

Images will be identified as normal, suspect or abnormal based upon each modality independently, paired with the spectral image and all three combined. The control will be an area considered normal by all modes of bronchoscopy. Images will be graded at the time of bronchoscopy. Later, all images will be graded in a blind fashion by two independent bronchoscopists. Standard statistical analysis using paired Student's t test will be applied. We anticipate that the combination of one or more imaged bronchoscopy techniques will increase accuracy by 25%. Power calculation to detect such a difference will require 140 abnormal specimens. If 50% of patients examined have an abnormality, the study population will need to be around 300 patients.

Histopathology reports will be obtained on all specimens. Abnormal results will be discussed with the individual patient and appropriate procedures will be performed based upon best medical practices. These procedures and patient follow-up are beyond the scope of the study.

  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

Any patient with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy

Criteria

Inclusion Criteria:

  • Patients with lung abnormalities that have an indication for bronchoscopy

Exclusion Criteria:

  • Inability to tolerate bronchoscopy
  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: NCT00548730

Contacts
Contact: Joseph LoCicero, MD 718-283-7272 jlocicero@maimonidesmed.org
Contact: Richard S Lazzaro, MD 718-283-7272 rlazzaro@maimonidesmed.org

Locations
United States, New York
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Joseph LoCicero, MD    718-283-7272    jlocicero@maimonidesmed.org   
Contact: Richard S Lazzaro, MD    718-283-7272    rlazzaro@maimonidesmed.org   
Principal Investigator: Joseph LoCicero, MD         
Sub-Investigator: Richard S Lazzaro, MD         
Sponsors and Collaborators
Maimonides Medical Center
Investigators
Principal Investigator: Joseph LoCicero, MD Maimonides Medical Center
  More Information

Publications:

Responsible Party: Joseph LoCicero, III, MD, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT00548730     History of Changes
Other Study ID Numbers: MMC07/06VA14
Study First Received: October 22, 2007
Last Updated: February 6, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Maimonides Medical Center:
Bronchoscopy
Endoscopy
Image Enhancement
Autofluorescence
Narrow Band Image

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 19, 2014