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

NCT00548730 | Withdrawn

• 1 other identifier: MMC07/06VA14
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

Bronchoscopy; Endoscopy; Image Enhancement; Autofluorescence; Narrow Band Image

Outcome Measures

Primary Outcomes (1)

• Degree of correlation between three different bronchoscopic images

  One day

Secondary Outcomes (1)

• Elimination of false positives and negative bronchoscopic examinations for neoplasia

  One day

Study Arms (3)

White Light Bronchoscopy

Patients with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy will have images taken with white light bronchoscopy

Procedure: Bronchoscopy

Autofluorescence Bronchoscopy

Patients with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy will have images taken with autofluorescence bronchoscopy

Procedure: Bronchoscopy

Narrow Band Imaged Bronchoscopy

Patients with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy will have images taken with narrow band imaged bronchoscopy

Procedure: Bronchoscopy

Interventions

Bronchoscopy PROCEDURE

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.

Also known as: AF bronchoscope (11004BI), NBI bronchoscope (BF-T180)

Autofluorescence Bronchoscopy; Narrow Band Imaged Bronchoscopy; White Light Bronchoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients with lung abnormalities that have an indication for bronchoscopy

You may not qualify if:

• Inability to tolerate bronchoscopy

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (7)

• 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.

  PMID: 10618453 BACKGROUND

• 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. doi: 10.1117/1.1695563.

  PMID: 15189095 BACKGROUND

• 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. doi: 10.1378/chest.06-2794. Epub 2007 May 15.

  PMID: 17505042 BACKGROUND

• 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. doi: 10.1016/j.lungcan.2007.04.009. Epub 2007 May 29.

  PMID: 17532537 BACKGROUND

• 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. doi: 10.1159/000093233. Epub 2006 May 5.

  PMID: 16679756 BACKGROUND

• 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. doi: 10.3346/jkms.2006.21.2.242.

  PMID: 16614508 BACKGROUND

• 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. doi: 10.1136/thx.2005.041475.

  PMID: 15923251 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Endobronchial biopsies of normal and abnormal mucosa for histopathology

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Joseph LoCicero, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Administration Director

Study Record Dates

• First Submitted: October 22, 2007
• First Posted: October 24, 2007
• Study Start: October 1, 2007
• Primary Completion: May 31, 2009
• Study Completion: May 31, 2009
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

US (1)