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Diagnostic Effectiveness of Virtual Bronchoscopy

Primary Purpose

Bronchogenic Carcinoma, Chronic Granulomatous Disease, Job's Syndrome

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
virtual bronchoscopy
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchogenic Carcinoma focused on measuring Wegener's Granulomatosis, Computer Assisted Visualization, Lung Cavities, Endobronchial Lesions, Computed Tomography (CT), Bronchogenic Carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Warren G. Magnuson Clinical Center (CC)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institutes of Health Clinical Center (CC)
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1. Study Identification

Unique Protocol Identification Number
NCT00001515
Brief Title
Diagnostic Effectiveness of Virtual Bronchoscopy
Official Title
Diagnostic Efficacy of Virtual Bronchoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2001
Overall Recruitment Status
Completed
Study Start Date
December 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institutes of Health Clinical Center (CC)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchogenic Carcinoma, Chronic Granulomatous Disease, Job's Syndrome, Mycobacterium Infection, Wegener's Granulomatosis
Keywords
Wegener's Granulomatosis, Computer Assisted Visualization, Lung Cavities, Endobronchial Lesions, Computed Tomography (CT), Bronchogenic Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
virtual bronchoscopy

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Warren G. Magnuson Clinical Center (CC)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8756944
Citation
Summers RM, Feng DH, Holland SM, Sneller MC, Shelhamer JH. Virtual bronchoscopy: segmentation method for real-time display. Radiology. 1996 Sep;200(3):857-62. doi: 10.1148/radiology.200.3.8756944.
Results Reference
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PubMed Identifier
9129406
Citation
Summers RM. Navigational aids for real-time virtual bronchoscopy. AJR Am J Roentgenol. 1997 May;168(5):1165-70. doi: 10.2214/ajr.168.5.9129406.
Results Reference
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PubMed Identifier
9530041
Citation
Summers RM, Shaw DJ, Shelhamer JH. CT virtual bronchoscopy of simulated endobronchial lesions: effect of scanning, reconstruction, and display settings and potential pitfalls. AJR Am J Roentgenol. 1998 Apr;170(4):947-50. doi: 10.2214/ajr.170.4.9530041. No abstract available.
Results Reference
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Diagnostic Effectiveness of Virtual Bronchoscopy

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