New light therapy for treating peripheral lung cancer
Novel Light Delivery Method for Performing Transbronchial Photodynamic Therapy Ablation to Treat Peripheral Lung Cancer: A Second Phase Pilot Study
This study is testing a new light therapy for people with hard-to-treat lung tumors to see if it can help them better than traditional treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | All |
| Sponsor | Taoyuan General Hospital Government |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Taoyuan City) |
| Trial ID | NCT06262555 on ClinicalTrials.gov |
What this trial studies
This research aims to develop an innovative photodynamic therapy (PDT) for treating peripheral lung tumors, which are often challenging to manage with conventional methods like surgery and chemotherapy. The approach involves using a contrast agent, Lipiodol, instilled into the trachea via bronchoscopy to enhance light delivery to the tumor. Preliminary trials in pig models have shown safety, and this phase I trial will assess the safety and efficacy of multiple light treatments from different angles, with an additional dose after 48 hours. The findings will inform future clinical trials to optimize PDT dosage for better patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced or terminal malignant lung tumors that are less than or equal to 3 cm and have failed or are unsuitable for standard treatments.
Not a fit: Patients with small cell lung cancer, central lung tumors, or those who have received recent chemotherapy or radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a minimally invasive treatment option for patients with advanced lung cancer who have exhausted standard treatment options.
How similar studies have performed: While photodynamic therapy has shown promise in treating central airway lung cancer, this specific approach for peripheral tumors is novel and has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Taoyuan City
- Taoyuan General Hospital, Ministry of Health and Welfare — Taoyuan City, Taiwan (Recruiting)
Study contacts
- Principal investigator: Yei San Hsieh — Taoyuan General Hospital
- Study coordinator: Yei San Hsieh
- Email: yeisanh@gmail.com
- Phone: +886975061108
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.