Diagnostic Effectiveness of Virtual Bronchoscopy

NCT00001515 | Completed Phase 1

• 2 other identifiers: 96002196-CC-0021
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Interventions

virtual bronchoscopy DEVICE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

Warren G. Magnuson Clinical Center (CC)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 8756944 BACKGROUND

• 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.

  PMID: 9129406 BACKGROUND

• 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.

  PMID: 9530041 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Bronchogenic; Granulomatous Disease, Chronic; Job Syndrome; Mycobacterium Infections; Granulomatosis with Polyangiitis

Condition Hierarchy (Ancestors)

Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Phagocyte Bactericidal Dysfunction; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Primary Immunodeficiency Diseases; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Lung Diseases, Interstitial; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: December 1, 1995
• Study Completion: November 1, 2001
• Last Updated: March 4, 2008

Record last verified: 2001-11

Locations

US (1)