Novel Light Delivery Method for Performing Transbronchial Photodynamic Therapy Ablation to Treat Peripheral Lung Cancer: A Second Phase Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Technical Feasibility
研究概览
简要总结
This research aims to develop an innovative photodynamic therapy (PDT) for peripheral lung tumors. Current treatments involve surgery, chemotherapy, and radiation. Photodynamic therapy, using light and photosensitizing drugs, is promising but has limitations. Our team proposes using Lipiodol, a contrast agent, instilled into the trachea via bronchoscopy, surrounding the tumor. Preliminary pig model trials showed safety. Clinical trials, building on a U.S. study (NCT02916745), commenced in October 2021, treating three cases. Initial results suggest safety, but efficacy requires further investigation. Based on ongoing trials, we propose a phase I trial with multiple light treatments from different directions and an additional dose after 48 hours to assess safety and efficacy. This study will guide future clinical trials for optimal PDT dosage.
详细描述
The main focus of this research is the development of an innovative photodynamic therapy (PDT) mode applied to peripheral lung tumors. Current treatments for lung tumors, including primary lung cancer or metastatic tumors to the lungs, involve surgery, chemotherapy (including targeted and immunotherapy), and radiation therapy. The choice of treatment depends on factors such as tumor size, invasion, genetic characteristics, and the overall health of the patient.
For early-stage peripheral lung tumors, there is a continuous effort to develop minimally invasive treatment modalities to replace current surgical methods. Techniques such as computed tomography-guided percutaneous or bronchoscopic-guided radiofrequency ablation (RFA), microwave ablation, and photodynamic therapy are actively under research and development. Photodynamic therapy utilizes special photosensitizing drugs selectively absorbed by cancer cells, followed by exposure to light of specific wavelengths, triggering a reaction that destroys cancer cells.
Although photodynamic therapy has been successful in treating early-stage central airway lung cancer or advanced tumors causing airway obstruction, it has limitations. The penetration of light is restricted, resulting in a treatment range of approximately 1.5 to 2 centimeters in diameter. Multiple guidance and light treatments are needed to cover the entire tumor, increasing the technical difficulty of the procedure.
Light travels in a straight line and undergoes penetration, absorption, and reflection when encountering tissue interfaces, limiting its penetration within tissues. Dr. Friedberg in the United States proposed a novel lighting mode in 2003, using materials with high refractive indices, such as mineral oil (refractive index approximately 1.47), to enable light conduction in the trachea and bronchi. However, mineral oil is harmful to lung tissue, causing severe complications if inadvertently inhaled into the airways.
In this study, Lipiodol, a contrast agent with a refractive index of 1.47, was considered as a potential alternative to mineral oil. Lipiodol is a mixture of poppy seed oil and iodine ions and is commonly used in lymphography or for embolization therapy of liver tumors. It has been used for years in clinical practice for bronchoscopic instillation as a means of visualizing and locating lung tumors.
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
- •Patients diagnosed with advanced or terminal malignant lung tumors (including primary lung cancer and lung metastases from other cancers).
- •Patients who have failed standard treatments (surgery, radiotherapy, or first and second-line chemotherapy/immunotherapy/targeted therapy) or are unsuitable for standard treatments.
- •Tumor size less than or equal to 3 cm, clearly assessable on chest computed tomography.
- •Patients capable of providing informed consent and willing to undergo regular follow-ups during the trial.
排除标准
- •Diagnosis of small cell lung cancer or non-solid malignancies.
- •Tumors located in the central part of the lungs.
- •Previous radiation therapy to the treatment site.
- •Abnormal blood biochemical values.
- •Chemotherapy received within the past 4 weeks.
- •Tumor invading major blood vessels.
- •Allergy to porphyrins or porphyrin-related metabolites, or allergy to Lipiodol or iodine-containing contrast agents.
- •Planning radical surgery for lung tumors within the next 90 days.
- •Potential need for slit lamp ophthalmic examination within the next 30 days due to existing eye diseases.
- •Inability to undergo bronchoscopy due to mental health conditions.
- •Pregnancy, planning pregnancy, breastfeeding, or planning to breastfeed within the next 6 months.
- •Previous photodynamic therapy within the past 1 month.
- •Severe kidney or liver disease with abnormal function.
- •Planning to participate in other cancer treatment clinical trials within the next 3 months.
- •HIV-positive patients.
- •Individuals deemed unsuitable for the trial by the principal investigator and the safety monitoring committee due to severe illnesses.
研究组 & 干预措施
Arm 1
Photophrin 2mg/kg 48 hours before treatment. Navigational bronchoscope guide the catheter into the tumor and adjacent to the tumor and give lipiodol for light diffusion and give light 200J/cm from different angle
干预措施: Transbronchial PDT peripheral lung tumor ablation (Procedure)
结局指标
主要结局
Technical Feasibility
时间窗: 3 days
Number of times photodynamic therapy was delivered into the tumor using navigational bronchoscopy for each subject
Technical Safety
时间窗: 6 months
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.
次要结局
- Tumor remission rate(3 months)
研究者
Clinical Research Center
Chief of Thoracic Surgery Department
Taoyuan General Hospital