Novel Light Delivery Method for Performing Transbronchial Photodynamic Therapy for Peripheral Lung Cancer

Summary

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.

Eligibility

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Conditions3

Browse More Trials