Comparison Trial of White Light, Autofluorescence and Narrow Band Imaging Bronchoscopy - Full Text View

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

MedlinePlus related topics:

Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	A Clinical Comparison Trial of White Light Bronchoscopy, Autofluorescence Bronchoscopy and Narrow Band Imaged Bronchoscopy

Further study details as provided by Maimonides Medical Center:

Primary Outcome Measures:

Degree of correlation between three different bronchoscopic images [ Time Frame: One day ]

Secondary Outcome Measures:

Elimination of false positives and negative bronchoscopic examinations for neoplasia [ Time Frame: One day ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Endobronchial biopsies of normal and abnormal mucosa for histopathology

Estimated Enrollment:	100
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2008

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 videobronchoscope. Biopsies are taken of a normal region and all abnormal regions.

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 videobronchoscope (BF-T180; Olympus; Center Valley, PA). Both systems are available and in routine use at Maimonides Medical Center.

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

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:

DaCosta RS, Wilson BC, Marcon NE. Light-induced fluorescence endoscopy of the gastrointestinal tract. Gastrointest Endosc Clin N Am. 2000 Jan;10(1):37-69, vi. Review.

Gono K, Obi T, Yamaguchi M, Ohyama N, Machida H, Sano Y, Yoshida S, Hamamoto Y, Endo T. Appearance of enhanced tissue features in narrow-band endoscopic imaging. J Biomed Opt. 2004 May-Jun;9(3):568-77.

Vincent BD, Fraig M, Silvestri GA. A pilot study of narrow-band imaging compared to white light bronchoscopy for evaluation of normal airways and premalignant and malignant airways disease. Chest. 2007 Jun;131(6):1794-9. Epub 2007 May 15.

Lee P, Brokx HA, Postmus PE, Sutedja TG. Dual digital video-autofluorescence imaging for detection of pre-neoplastic lesions. Lung Cancer. 2007 Oct;58(1):44-9. Epub 2007 May 29.

Ueno K, Kusunoki Y, Imamura F, Yoshimura M, Yamamoto S, Uchida J, Tsukamoto Y. Clinical experience with autofluorescence imaging system in patients with lung cancers and precancerous lesions. Respiration. 2007;74(3):304-8. Epub 2006 May 5.

Jang TW, Oak CH, Chun BK, Jung MH. Detection of pre-invasive endobronchial tumors with D-light/autofluorescence system. J Korean Med Sci. 2006 Apr;21(2):242-6.

Haussinger K, Becker H, Stanzel F, Kreuzer A, Schmidt B, Strausz J, Cavaliere S, Herth F, Kohlhaufl M, Muller KM, Huber RM, Pichlmeier U, Bolliger ChT. Autofluorescence bronchoscopy with white light bronchoscopy compared with white light bronchoscopy alone for the detection of precancerous lesions: a European randomised controlled multicentre trial. Thorax. 2005 Jun;60(6):496-503.

Study ID Numbers:	MMC07/06VA14
First Received:	October 22, 2007
Last Updated:	October 22, 2007
ClinicalTrials.gov Identifier:	NCT00548730
Health Authority:	United States: Institutional Review Board