Diagnostic Effectiveness of Virtual Bronchoscopy

March 3, 2008 updated by: National Institutes of Health Clinical Center (CC)

Diagnostic Efficacy of Virtual Bronchoscopy

This study will evaluate a new technique for examining the air passages of the lungs called "virtual bronchoscopy." It involves using computed tomography (CT) images of the chest to generate a 3-dimensional model of the walls of the trachea and bronchi (airway passages). This non-invasive method lets doctors see small masses and areas of narrowing in the passages without having to do surgery or pass a tube through them.

Patients with diseases of the air passages who are enrolled in an NIH clinical trial may participate in this study, which requires having a CT scan. The patient lies on a table that slowly slides into a hole in a donut-shaped X-ray machine (the scanner). Patients may have to hold their breath several times during the procedure. Some patients may be given an injection of a contrast agent through a catheter (thin tube) placed in an arm vein to improve visibility of abnormalities. Patients may also be asked to breathe oxygen through nasal prongs to allow them to hold their breath longer. The procedure usually takes 15 to 20 minutes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This project is a test of the efficacy of a new diagnostic method for imaging the airways known as virtual bronchoscopy. Virtual bronchoscopy is performed by acquiring thin section computed tomography (CT) images of the chest. These images are used to generate a three dimensional model of the tracheal and bronchial walls on a graphics workstation in 3-D. The model can be manipulated to allow the viewer to "fly through" the tracheobronchial tree providing views similar to those obtained during bronchoscopy. The technique produces a display of the human bronchial system in a readily understood format. Moreover, it allows investigation of post-stenotic portions of the bronchial tree that are beyond the reach of fiberoptic bronchoscopy. Further, virtual bronchoscopy may be used to guide interventional procedures. The patients that will be studied in this protocol will be those having inflammatory, infectious, or neoplastic pulmonary processes who would have had a chest CT for clinical reasons. These patients will be recruited from current NIH protocols. The study design consists of scanning of the thorax using thin section helical CT, followed by three dimensional surface rendering of the airways and transfer of the digital data to videotape. In one of four parts of the protocol, the virtual bronchoscopy will be compared with results from fiberoptic bronchoscopy in a blinded study. In a second part of the protocol, the virtual bronchoscopy will be used to perform a descriptive analysis of cavitary lung lesions. In the third part, the utility of virtual bronchoscopy in diagnosis of neoplastic lesions of the chest will be studied. In the fourth part, certain technical problems in the virtual bronchoscopy procedure will be investigated. The patients will only have fiberoptic bronchoscopy for clinically indicated purposes. We anticipate that virtual bronchoscopy will be diagnostically efficacious for disorders which produce a morphologic alteration in bronchial anatomy.

Study Type

Interventional

Enrollment

120

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Warren G. Magnuson Clinical Center (CC)

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Patients with Wegener's granulomatosis who are scheduled for fiberoptic bronchoscopy.

Patients with cavitary lung diseases who are enrolled in protocols studying patients with Wegener's granulomatosis, chronic granulomatosis disease, host immune defects, mycobacterial infections, and Job's syndrome.

Patients with bronchogenic carcinoma, other thoracic malignancies, or metastatic disease to the thorax.

Patients will be selected from Clinical Center inpatient and outpatient population based on a clinical suspicion of pulmonary, mediastinal or bronchial disease, and are to have medically indicated chest CT.

Written informed consent will be obtained from all patients and studies will only be done with the permission of the patient's attending physician.

Patients will be drawn from the following protocols:

92-I-0186

93-I-0119

94-I-0149

95-I-0091

90-I-0086

76-I-0023

92-I-0255

93-I-0172

95-I-0177

Subjects must not be pregnant and be able to hold their breath for required periods of time.

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

  • Primary Purpose: Treatment

Collaborators and Investigators

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

Sponsor

National Institutes of Health Clinical Center (CC)

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

December 1, 1995

Study Completion

November 1, 2001

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

November 3, 1999

First Posted (Estimate)

November 4, 1999

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

November 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 960021
  • 96-CC-0021

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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