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

December 8, 2023 updated by: Antonios Likourezos

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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

Description

Inclusion Criteria:

  • Patients with lung abnormalities that have an indication for bronchoscopy

Exclusion Criteria:

  • Inability to tolerate bronchoscopy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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)
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
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)
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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Degree of correlation between three different bronchoscopic images
Time Frame: One day
One day

Secondary Outcome Measures

Outcome Measure
Time Frame
Elimination of false positives and negative bronchoscopic examinations for neoplasia
Time Frame: One day
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antonios Likourezos

Investigators

  • Principal Investigator: Joseph LoCicero, MD, Maimonides Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2007

Primary Completion (Actual)

May 31, 2009

Study Completion (Actual)

May 31, 2009

Study Registration Dates

First Submitted

October 22, 2007

First Submitted That Met QC Criteria

October 22, 2007

First Posted (Estimated)

October 24, 2007

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MMC07/06VA14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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