Viewing Study NCT00001515



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Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00001515
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 1999-11-03

Brief Title: Diagnostic Effectiveness of Virtual Bronchoscopy
Sponsor: National Institutes of Health Clinical Center CC
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Diagnostic Efficacy of Virtual Bronchoscopy
Status: COMPLETED
Status Verified Date: 2001-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
96-CC-0021 None None None