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Ex-Vivo COF Study for Lung Cancer Observation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04534413
Recruitment Status : Recruiting
First Posted : September 1, 2020
Last Update Posted : September 1, 2020
Information provided by (Responsible Party):
Yasufuku Research Team, University Health Network, Toronto

Brief Summary:

Accessing nodules located in the most outer part of the lung is challenging. Tissue that will be removed from the lung will be used to see if we can reach and see the nodule with a very small camera. This camera that may reach in the smaller and outer airways is called a composite optical fiberscope (COF).

The purpose of this study is to evaluate insertion ability of the COF and visualization of the lung tumor by the COF. In order to do so, we plan to evaluate 50 patient samples from the University Health Network over the span of 2 years.

Condition or disease Intervention/treatment
Lung Cancer Device: composite optical fiberscope (COF)

Detailed Description:

Peripheral pulmonary lesions (PPLs), which include pulmonary nodules and masses, are a common problem in pulmonology practice. The incidence of PPLs will likely increase given the growing adoption of chest CT screening for lung cancer. There are several guidelines available for management of PPLs. If bronchoscopy is selected as the method of diagnosis, conventional bronchoscopy has been one platform used for decades to diagnose PPLs. However, conventional bronchoscopic techniques have significant limitations and overall low diagnostic yield for most PPLs. As a result, innovative bronchoscopic techniques and technologies have evolved over the last decade to diagnose PPLs more accurately. However, accessing to PPLs located in the most peripheral part is still challenging.

As a new method to diagnose and localize cancers, photodynamic diagnosis (PDD) has been gaining attention. PDD is a new technique where a photosensitizer injected intravenously accumulates in the abnormal lesion, then its fluorescence can be detected by a detector. To conduct PDD for PPLs, we collaboratively developed a parallel-type composite optical fiberscope (COF) with an outer tip diameter of 0.97 mm with OK Fiber Technology (Kyoto, Japan). Its small size and flexibility of the tip enable it to be inserted into animal ultrasmall airways. The outer membrane of the fiberscope is made from polytetrafluoroethylene in the COF's insertable section and is hydrophilic coated, which reduces frictional forces when in the contact with the bronchial wall resulting in smooth insertion of the fiberscope. As the COF has illumination fibers and a laser fiber inside, simultaneous white-light and fluorescence imaging with real-time monitoring can be performed to confirm the tip position of the fiberscope during laser irradiation. In this study, we want to evaluate the COF regarding the quality of white-light images and the accessibility of lung tumors located in the peripheral area of the lung.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Feasibility of the Ultrasmall Composite Optical Fiberscope System for Lung Cancer Observation
Actual Study Start Date : August 5, 2020
Estimated Primary Completion Date : August 5, 2023
Estimated Study Completion Date : August 5, 2023

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: composite optical fiberscope (COF)
    Fiber Technology

Primary Outcome Measures :
  1. insertion ability of the COF using human ex-vivo lungs [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patients scheduled for lobectomy or anatomical segmental resection for malignant lung tumors

Inclusion Criteria:

  1. Any patients scheduled for lobectomy or anatomical segmental resection for malignant lung tumors.
  2. 18 years of age or older.

Exclusion Criteria:

1) Any patients with inability to give informed consent.

Information from the National Library of Medicine

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 identifier (NCT number): NCT04534413

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Contact: Judy McConnell 416-581-7486

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Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 1L7
Contact: Judy McConnell, BSc.Hon, CCRP    416-581-7486   
Sponsors and Collaborators
University Health Network, Toronto
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Responsible Party: Yasufuku Research Team, Dr. Kazuhiro Yasufuku, University Health Network, Toronto Identifier: NCT04534413    
Other Study ID Numbers: 20-5565
First Posted: September 1, 2020    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases