A Multicenter, Prospective, Open Label, Single-Arm Clinical Study of the Safety and Feasibility of Using Navigational Bronchoscopy to Perform Photodynamic Therapy using PHOTOFRIN® as Treatment in Subjects with Unresectable Solid Tumor in Peripheral Lung

Purpose

This research study is being conducted to assess the safety and feasibility of using a new developed bronchoscopic technology called electronavigational bronchoscopy to treat subjects with solid tumor in peripheral lung, who are inoperable or refused surgery. It will involve 10 sites in USA and Canada. Participation will last 6 months.

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) have shown to enable physicians to safely reach lesions in peripheral regions of the lung and obtain 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 bronchoscope. The light activates the porfimer sodium, which is concentrated in the abnormal tissue, leading to its destruction.

The purpose of this study is to determine if physicians can reach the tumors in the periphery of the lung via electronavigational bronchoscopy and deliver the photodynamic therapy by placing the optical fiber into the tumor.

Age

18 to 65
65 and over

Gender

N/A

Monetary compensation

No

Can be done from home

No

Keywords

Porfimer sodium

Principal Investigator

Hiren Mehta, M.D.

Sponsoring Group

Department of Medicine

Department

Department of Medicine

Contact Information

Hiren.Mehta@medicine.ufl.edu

352.273.8740


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