Brooklyn, New York 11219


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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Patients with lung abnormalities that have an indication for bronchoscopy Exclusion Criteria: - Inability to tolerate bronchoscopy


NCT ID:

NCT00548730


Primary Contact:

Principal Investigator
Joseph LoCicero, MD
Maimonides Medical Center

Joseph LoCicero, MD
Phone: 718-283-7272
Email: jlocicero@maimonidesmed.org


Backup Contact:

Email: rlazzaro@maimonidesmed.org
Richard S Lazzaro, MD
Phone: 718-283-7272


Location Contact:

Brooklyn, New York 11219
United States

Joseph LoCicero, MD
Phone: 718-283-7272
Email: jlocicero@maimonidesmed.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 21, 2017

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