Novel Light Delivery Method for Performing Transbronchial Photodynamic Therapy Ablation to Treat Peripheral Lung Cancer: A Second Phase Pilot Study
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.
• 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.