NCT04753918

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

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: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 3 (estimated)
• Sponsor: Taoyuan General Hospital · Other Government
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

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

Interventions

Type	Name	Description
DRUG	Porfimer sodium	Photofrin 2mg/kg was iv injected 48-50 hours before light illumination.
DRUG	Ethiodized oil	In hybrid operation room setting, a navigational bronchoscope guide sheath was inserted to the proximal end of the tumor region. About 5 ml Lipiodol was infused to full cover whole the tumor.
PROCEDURE	Novel light delivery methods of photodynamic therapy	Using high-refraction index contrast medium: lipiodol as a light diffusor to enhance the range of photodynamic therapy
DEVICE	Fiber optic	A cylindrical laser fiber was then inserted through the guide sheath to the tumor region then illuminate light to complete the photodynamic therapy.

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-09-01
• Completion: 2022-02-01
• First posted: 2021-02-15
• Last updated: 2021-02-15

Regulatory

• FDA-regulated drug study
• FDA-regulated device study