Completed

Diagnostic Efficacy of Virtual Bronchoscopy

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What is being tested

virtual bronchoscopy

Device
Who is being recruted

Primary Immunodeficiency Diseases+39

+ Actinomycetales Infections

+ Autoimmune Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: December 1995
See protocol details

Summary

Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 1995

Actual date on which the first participant was enrolled.

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.

NCT00001515
Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Primary Immunodeficiency DiseasesActinomycetales InfectionsAutoimmune DiseasesBacterial Infections and MycosesBacterial InfectionsBronchial NeoplasmsCardiovascular DiseasesChronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsLeukocyte DisordersLung DiseasesLung NeoplasmsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasmsNeoplasms by SitePathologic ProcessesPhagocyte Bactericidal DysfunctionRespiratory Tract DiseasesRespiratory Tract NeoplasmsSkin DiseasesPathological Conditions, Signs and SymptomsThoracic NeoplasmsVascular DiseasesVasculitisGram-Positive Bacterial InfectionsSkin and Connective Tissue DiseasesSkin Diseases, VascularLung Diseases, InterstitialDisease AttributesGenetic Diseases, InbornGenetic Diseases, X-LinkedSystemic VasculitisAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisCarcinoma, BronchogenicGranulomatous Disease, ChronicJob SyndromeMycobacterium InfectionsGranulomatosis with Polyangiitis

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Warren G. Magnuson Clinical Center (CC)

Bethesda, United StatesOpen Warren G. Magnuson Clinical Center (CC) in Google Maps
CompletedOne Study Center