Multicenter, Prospective, OL, Single-arm Clinical Study of Safety & Feasibility of Using Navigational Bronchoscopy to Perform Interstitial PD Therapy Using Photofrin® as Treatment in Subjects With Unresectable Solid Tumor in Peripheral Lung
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 7
- 主要终点
- Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) 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 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.
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) 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.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 or older
- •Diagnosed with histologically confirmed solid tumor located in the peripheral lung
- •Not candidate for curative surgery, is unfit for surgery, or does not wish to undergo curative surgery
- •May be candidate for, have failed, or does not wish to undergo radiation therapy
- •The tumor is ≤ 3 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
- •Solid tumor located in central lung
- •Presence of concurrent non-solid malignancy
- •Abnormal blood results
- •Received chemotherapy/immunotherapy in the last 4 weeks
- •Tumor invades a major blood vessel
- •Porphyria or known hypersensitivity to Photofrin® or porphyrin-like compounds or to any of its excipients
- •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 3 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
研究组 & 干预措施
Photodynamic therapy-Photofrin
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
干预措施: Porfimer sodium (Drug)
Photodynamic therapy-Photofrin
Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.
干预措施: Fiber optic (Device)
结局指标
主要结局
Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) 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 Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT)
时间窗: Up to 6 months
The incidence of adverse events following navigational bronchoscopy-iPDT (interstitial-Photodynamic Therapy) 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)(Up to 6 months)
- Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline.(up to day 0 (-14 to -1 days))
- Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection).(1 day)
- Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy)(Day 3)
- Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection)(Day 30)
- Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection(up to 3 months)
- Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection(Up to 6 months)
- Short Form Health Survey (SF-36) Score at Baseline(Baseline)
- Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score(up to 3 months)
- Short-Form Health Survey (SF-36) Score at Follow-up Visit at 3 Months.(up to 3 months)
- Short-Form Health Survey (SF-36) Score at Study Exit (6 Month Visit)(Up to 6 months)
- Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline(Baseline)
- Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months(up to 3 months)
- Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months(Up to 6 months)
- Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score(Baseline)
- Safety: Physical Examination Summaries for Each Subject(Up to 6 months)
- Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events(Up to 6 months)
- Safety: Laboratory Test Summaries for Each Subject(Up to 6 months)
- Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score(Up to 6 months)
- Number of Participants With Indicated Adverse Events(Up to 6 months post-treatment)
- Number of Subjects With at Least One Serious Adverse Event(Up to 6 months)
- Safety: Number of Participants With Indicated Vital Sign Summaries(Up to 6 months)