Pilot Study To Evaluate Optical Frequency Domain Imaging For Diagnosis Of Central Airway Disease
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|ClinicalTrials.gov Identifier: NCT00784329|
Recruitment Status : Active, not recruiting
First Posted : November 3, 2008
Last Update Posted : August 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Lung Cancer Lung Cancer Pulmonary Disease||Device: Optical Frequency Domain Imaging (OFDI) System||Not Applicable|
This study will evaluate the potential of a new imaging device, the Optical Frequency Domain Imaging (OFDI) for imaging pulmonary malignancy in the central airways.
The prevalence and high mortality rate associated with Lung Squamous Cell Carcinoma and the lack of any widely accepted screening and surveillance tools, highlights the need for new imaging paradigms that will ultimately lead to a reduction in patient mortality.
Bronchial carcinoma in-situ will progress to invasive cancer in over 40% of individuals, and although the progression occurs over a long period of time, the majority of carcinomas are detected in the later stages of disease development, offering patients only a very slim chance of cure. Although, significant effort in the development of screening paradigms for the detection of lung cancer in the central airway has been made, to date there is still no widely accepted and validated approach. Optical Frequency Domain Imaging (OFDI) is a recent derivative of optical coherence tomography (OCT). As in OCT, OFDI is an interferometric ranging technique that can roughly be considered to be an optical analogue of ultrasound imaging and can provide tomographic images of tissue at resolutions comparable with architectural histology. The long term goal of this study is to use OFDI to screen the airways with the hope of detecting Squamous Cell Carcinoma at an earlier more curable stage.
Standard of care bronchoscopy preparation and procedures to be followed, with moderate sedation, pulse oximetry and blood pressure monitoring as per department protocol. A combination of currently approved bronchoscopy techniques including stand white light bronchoscopy, autofluorescence bronchoscopy, and narrow band imaging will be used to assess the airways.
Bronchial regions of interest (ROI's)suspected to be premalignant or malignant, identified during the bronchoscopy procedure, will be imaged using the OFDI system and catheter before biopsy is done. It is anticipated to obtain a minimum of 3 OFDI-biopsy correlated pairs from each study participant. An additional OFDI image and biopsy will be obtained from region's of normal interest (ROI's). It is expected that the experimental procedure will add less than 10 minutes to the total length of the bronchoscopy procedure, but a stopping rule will be instituted to ensure that the experimental procedure does not exceed 20 minutes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study To Evaluate Optical Frequency Domain Imaging For Diagnosis Of Central Airway Disease|
|Actual Study Start Date :||March 2008|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Optical Frequency Domain Imaging
Optical Frequency Domain Imaging System used during Lung and Bronchial biopsies to detect cancerous tissue. Tissue imaging results will be compared to tissue biopsy results.
Device: Optical Frequency Domain Imaging (OFDI) System
Optical Frequency Domain Imaging(OFDI)System. Additional biopsy obtained from regions of normal appearing tissue. Up to an additional 20 minutes to standard Bronchoscopy
- Obtain biopsy correlated OFDI images with the purpose of establishing OFDI image criteria for discrimination of tissue types. [ Time Frame: One time Bronchoscopy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784329
|United States, Massachusetts|
|Lahey Clinic, Inc.|
|Burlington, Massachusetts, United States, 01805|
|Principal Investigator:||Anthony W Bonhert, M.D.||Lahey Clinic, Inc.|