Ex-Vivo COF Study for Lung Cancer Observation

Lung Cancer Clinical Trial

Official title:

Feasibility of the Ultrasmall Composite Optical Fiberscope System for Lung Cancer Observation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04534413
• Other study ID #: 20-5565
• Status: Recruiting
• Start date: August 5, 2020
• Est. completion date: December 5, 2024

Study information

• Verified date: November 2023
• Source: University Health Network, Toronto
• Contact: Judy McConnell
• Phone: 416-581-7486
• Email: judy.mcconnnell[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 5, 2024
• Est. primary completion date: December 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Device:
• composite optical fiberscope (COF)
Fiber Technology

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insertion ability of the COF using human ex-vivo lungs		3 years