Ex-Vivo COF Study for Lung Cancer Observation

NCT ID: NCT04534413

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-05
• Study Completion Date: 2026-12-05

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.

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.

Conditions

Lung Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

composite optical fiberscope (COF)

Fiber Technology

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Kazuhiro Yasufuku

Dr. Kazuhiro Yasufuku

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Toronto General Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

20-5565

Identifier Type: -

Identifier Source: org_study_id