Diagnostic Effectiveness of Virtual Bronchoscopy

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Brief Title

Diagnostic Effectiveness of Virtual Bronchoscopy

Official Title

Diagnostic Efficacy of Virtual Bronchoscopy

Brief Summary

      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.
    

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 Phase

Phase 1

Study Type

Interventional




Condition

Bronchogenic Carcinoma

Intervention

virtual bronchoscopy


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

120

Start Date

December 1995

Completion Date

November 2001


Eligibility Criteria

        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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00001515

Organization ID

960021

Secondary IDs

96-CC-0021


Study Sponsor

National Institutes of Health Clinical Center (CC)


Study Sponsor

, , 


Verification Date

November 2001