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Sponsored by: |
Maimonides Medical Center |
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Information provided by: | Maimonides Medical Center |
ClinicalTrials.gov Identifier: | NCT00548730 |
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 |
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Lung Cancer |
Procedure: Bronchoscopy |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | A Clinical Comparison Trial of White Light Bronchoscopy, Autofluorescence Bronchoscopy and Narrow Band Imaged Bronchoscopy |
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 |
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Observation
Patients with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Any patient with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy
Inclusion Criteria:
Exclusion Criteria:
Contact: Joseph LoCicero, MD | 718-283-7272 | jlocicero@maimonidesmed.org |
Contact: Richard S Lazzaro, MD | 718-283-7272 | rlazzaro@maimonidesmed.org |
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 |
Principal Investigator: | Joseph LoCicero, MD | Maimonides Medical Center |
Responsible Party: | Maimonides Medical Center ( Joseph LoCicero, III, MD ) |
Study ID Numbers: | MMC07/06VA14 |
Study First Received: | October 22, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00548730 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bronchoscopy Endoscopy Image Enhancement Autofluorescence Narrow Band Image |
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases |