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
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 3
- 主要终点
- Feasibility to Perform Novel Photodynamic Therapy Into Tumor
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged between 20 and 75
- •Diagnosed with histologically confirmed solid tumor located in the peripheral lung
- •Not candidate or failed of standard chemotherapy, radiotherapy or surgery
- •Primary lung cancer without mediastinal or distant lymph nodes metastasis (N0-N1)
- •The tumor is ≤ 2 cm in size and clearly observable in computerized tomography (CT scan)
- •Able to sign an informed consent
排除标准
- •Diagnostic of small cell lung cancer or non-solid malignancy
- •Solid tumor located in central lung
- •Primary lung cancer without distant metastasis (M0)
- •Received radiotherapy over the target tumor
- •Abnormal blood results
- •Received chemotherapy/immunotherapy in the last 4 weeks
- •Tumor invasion with major blood vessels
- •Allergy to porphyria or known hypersensitivity to Photofrin® or porphyrin-like compounds or to any of its excipients, allergy to Lipiodol or iodine-content contrast medium
- •Planned surgical procedure within the next 90 days
- •Coexisting ophthalmic disease likely to require slit-lamp examination within the next 90 days
- •Acute or chronic medical or psychological illnesses that prevent endoscopy procedures
- •Pregnant or intend to become pregnant, breastfeeding or intend to breastfeed during the study
- •Received PDT during the past 1 months
- •Severe impairment of your kidney or liver function
- •Participates or intends to participate in another drug study (other than observational studies) during the study
- •Victim of AIDS
- •Other critical condition that the investigator considered not suited for participation
研究组 & 干预措施
Novel light delivery methods for photodynamic therapy
High refraction-index contrast medium: Lipiodol injected in the bronchial tree can enhance the treatment extension of the photodynamic therapy
干预措施: Porfimer sodium (Drug)
Novel light delivery methods for photodynamic therapy
High refraction-index contrast medium: Lipiodol injected in the bronchial tree can enhance the treatment extension of the photodynamic therapy
干预措施: Ethiodized oil (Drug)
Novel light delivery methods for photodynamic therapy
High refraction-index contrast medium: Lipiodol injected in the bronchial tree can enhance the treatment extension of the photodynamic therapy
干预措施: Novel light delivery methods of photodynamic therapy (Procedure)
Novel light delivery methods for photodynamic therapy
High refraction-index contrast medium: Lipiodol injected in the bronchial tree can enhance the treatment extension of the photodynamic therapy
干预措施: Fiber optic (Device)
结局指标
主要结局
Feasibility to Perform Novel Photodynamic Therapy Into Tumor
时间窗: Day 3 post-treatment
Number of times photodynamic therapy was delivered into the tumor using navigational bronchoscopy for each subject.
Adverse Events Incidence Indicating Safety of Novel Photodynamic Therapy
时间窗: Up to 6 months
The incidence of adverse events following Novel PDT will be presented as the primary safety indicator for this treatment.
次要结局
- Tumor Response at 3 Months Post Photodynamic Therapy (PDT)(Up to 3 months)
- Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT)(From the start of treatment until 6 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria)