Diagnostic Effectiveness of Virtual Bronchoscopy

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001515
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: November 2001
  Purpose

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.


Condition Intervention Phase
Bronchogenic Carcinoma
Chronic Granulomatous Disease
Job's Syndrome
Mycobacterium Infection
Wegener's Granulomatosis
Device: virtual bronchoscopy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: Diagnostic Efficacy of Virtual Bronchoscopy

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 120
Study Start Date: December 1995
Estimated Study Completion Date: November 2001
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001515

Locations
United States, Maryland
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001515     History of Changes
Other Study ID Numbers: 960021, 96-CC-0021
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Wegener's Granulomatosis
Computer Assisted Visualization
Lung Cavities
Endobronchial Lesions
Computed Tomography (CT)
Bronchogenic Carcinoma

Additional relevant MeSH terms:
Job's Syndrome
Carcinoma
Carcinoma, Bronchogenic
Granulomatous Disease, Chronic
Mycobacterium Infections
Wegener Granulomatosis
Granuloma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Phagocyte Bactericidal Dysfunction
Leukocyte Disorders
Hematologic Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Immunologic Deficiency Syndromes
Immune System Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases, Interstitial
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Systemic Vasculitis

ClinicalTrials.gov processed this record on July 24, 2014