Novel Light Delivery Methods for Lung Cancer Photodynamic Therapy - A Pilot Study

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

Official title: Single Center, Prospective, Open Label, Single-arm Clinical Study of Safety & Feasibility of Using Navigational Bronchoscopy to Perform Interstitial PD Therapy Using Lipiodol® as a Light Deliver and Photofrin® as Treatment in Subjects With Unresectable Solid Tumor in Peripheral Lung

Status Not yet recruiting

Clinical Trial Summary

This research study is being conducted to assess the safety and feasibility of using a newly developed bronchoscopic light delivery method of photodynamic therapy to treat subjects with solid tumors in peripheral lung, who are inoperable or refused surgery.

Clinical Trial Description

Lung cancer accounts for almost one-third of cancer deaths. Cancer screening strategies have the potential to achieve a 20% reduction in death rates. Newly developed bronchoscopic technologies (such as navigational bronchoscopy in a hybrid operation room) have been shown to enable physicians to safely reach lesions in peripheral regions of the lung and obtain a diagnosis. This new technology may now potentially offer bronchoscopic therapeutic interventions, such as photodynamic therapy, to tumors that were previously unreachable due to their peripheral anatomic location.

Photodynamic therapy (PDT) uses a combination of a photosensitizing drug (a drug that is activated by light), called porfimer sodium (Photofrin®), and a light from a laser that emits no heat. This technique works to allow the medical doctor to specifically target and destroy abnormal or cancer cells while limiting damage to surrounding healthy tissue. The activation of the drug is done by lighting the abnormal area using a fiber-optic device (very fine fiber [like a fishing line] that permits light transmission) inserted into a flexible tube called a bronchoscope. The light activates the porfimer sodium, which is concentrated in the abnormal tissue, leading to its destruction. But the penetrating depth of light is about 1.5 to 2 cm limits the treatment range of tumor size.

We proposed a novel light delivery method of instilling a high-refractive-index (RI) liquid (Lipiodol) to enhance light delivery in the lung.

The purpose of this study is to determine if physicians can reach the tumors in the periphery of the lung via electro-navigational bronchoscopy in a hybrid operation room and inject the lipiodol to cover the whole tumor then deliver photodynamic therapy by placing the optical fiber into the tumor ;

Related Conditions & MeSH terms

• Lung Metastasis
• Lung Neoplasms
• Non-small Cell Lung Cancer (NSCLC)

• NCT number: NCT04753918
• Study type: Interventional
• Source: Taoyuan General Hospital
• Contact: Yei-San Hsieh, MD
• Phone: 886-975061108
• Email: yeisanh@gmail.com
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: March 2021
• Completion date: February 2022