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

October 22, 2007
February 6, 2009
October 2007
Not Provided
Degree of correlation between three different bronchoscopic images [ Time Frame: One day ] [ Designated as safety issue: No ]
Degree of correlation between three different bronchoscopic images [ Time Frame: One day ]
Complete list of historical versions of study NCT00548730 on ClinicalTrials.gov Archive Site
Elimination of false positives and negative bronchoscopic examinations for neoplasia [ Time Frame: One day ] [ Designated as safety issue: No ]
Elimination of false positives and negative bronchoscopic examinations for neoplasia [ Time Frame: One day ]
Not Provided
Not Provided
 
Comparison Trial of White Light, Autofluorescence and Narrow Band Imaging Bronchoscopy
A Clinical Comparison Trial of White Light Bronchoscopy, Autofluorescence Bronchoscopy and Narrow Band Imaged Bronchoscopy

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Endobronchial biopsies of normal and abnormal mucosa for histopathology

Non-Probability Sample

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

Lung Cancer
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)
Observation
Patients with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy
Intervention: Procedure: Bronchoscopy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2010
Not Provided

Inclusion Criteria:

  • Patients with lung abnormalities that have an indication for bronchoscopy

Exclusion Criteria:

  • Inability to tolerate bronchoscopy
Both
18 Years and older
No
Contact: Joseph LoCicero, MD 718-283-7272 jlocicero@maimonidesmed.org
Contact: Richard S Lazzaro, MD 718-283-7272 rlazzaro@maimonidesmed.org
United States
 
NCT00548730
MMC07/06VA14
No
Joseph LoCicero, III, MD, Maimonides Medical Center
Maimonides Medical Center
Not Provided
Principal Investigator: Joseph LoCicero, MD Maimonides Medical Center
Maimonides Medical Center
January 2009

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