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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Photofrin 2mg/kg was iv injected 48-50 hours before light illumination.
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.
Using high-refraction index contrast medium: lipiodol as a light diffusor to enhance the range of photodynamic therapy
Feasibility to Perform Novel Photodynamic Therapy Into Tumor
Number of times photodynamic therapy was delivered into the tumor using navigational bronchoscopy for each subject.
Time frame: Day 3 post-treatment
Adverse Events Incidence Indicating Safety of Novel Photodynamic Therapy
The incidence of adverse events following Novel PDT will be presented as the primary safety indicator for this treatment.
Time frame: Up to 6 months
Tumor Response at 3 Months Post Photodynamic Therapy (PDT)
From the start of treatment until 3 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Time frame: Up to 3 months
Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT)
Up to 6 months
Time frame: From the start of treatment until 6 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
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A cylindrical laser fiber was then inserted through the guide sheath to the tumor region then illuminate light to complete the photodynamic therapy.