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| Tracking Information | |||||||||
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| First Received Date ICMJE | October 22, 2007 | ||||||||
| Last Updated Date | February 6, 2009 | ||||||||
| Start Date ICMJE | October 2007 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Degree of correlation between three different bronchoscopic images [ Time Frame: One day ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Degree of correlation between three different bronchoscopic images [ Time Frame: One day ] | ||||||||
| Change History | Complete list of historical versions of study NCT00548730 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Elimination of false positives and negative bronchoscopic examinations for neoplasia [ Time Frame: One day ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
Elimination of false positives and negative bronchoscopic examinations for neoplasia [ Time Frame: One day ] | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Comparison Trial of White Light, Autofluorescence and Narrow Band Imaging Bronchoscopy | ||||||||
| Official Title ICMJE | A Clinical Comparison Trial of White Light Bronchoscopy, Autofluorescence Bronchoscopy and Narrow Band Imaged Bronchoscopy | ||||||||
| Brief Summary | The purpose of the study is to compare the three methods of bronchoscopic imaging to determine what combination is optimum to identify neoplastic mucosal abnormalities. The ability to decrease the rate of false-positive and false negative findings of bronchoscopy also will be studied for each spectroscopic technique separately and for their combination. |
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| Detailed Description | Patients with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy will be invited to participate in the study. All patients must be over 18 years old and must sign informed consent. The endoscopic examination of the bronchial tree will be performed using a commercially available flexible fluorescence bronchoscope (11004BI; Karl Storz; Culver City, CA) and the flexible white light video-bronchoscope (BF-T180; Olympus; Center Valley, PA). Images obtained will be photographed using both video recordings and parallel images of white light and imaged bronchoscopy. These digital images will be electronically stored and evaluated at a later time. Biopsies will be obtained of all suspected abnormalities. These will be correlated with the images. Images will be identified as normal, suspect or abnormal based upon each modality independently, paired with the spectral image and all three combined. The control will be an area considered normal by all modes of bronchoscopy. Images will be graded at the time of bronchoscopy. Later, all images will be graded in a blind fashion by two independent bronchoscopists. Standard statistical analysis using paired Student's t test will be applied. We anticipate that the combination of one or more imaged bronchoscopy techniques will increase accuracy by 25%. Power calculation to detect such a difference will require 140 abnormal specimens. If 50% of patients examined have an abnormality, the study population will need to be around 300 patients. Histopathology reports will be obtained on all specimens. Abnormal results will be discussed with the individual patient and appropriate procedures will be performed based upon best medical practices. These procedures and patient follow-up are beyond the scope of the study. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Cohort, Prospective | ||||||||
| Condition ICMJE | Lung Cancer | ||||||||
| Intervention ICMJE | Procedure: Bronchoscopy | ||||||||
| Study Arms / Comparison Groups | Patients with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | December 2010 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00548730 | ||||||||
| Responsible Party | Joseph LoCicero, III, MD, Maimonides Medical Center | ||||||||
| Study ID Numbers ICMJE | MMC07/06VA14 | ||||||||
| Study Sponsor ICMJE | Maimonides Medical Center | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Maimonides Medical Center | ||||||||
| Verification Date | January 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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