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

NCT06262555 | Recruiting DMC

• 1 other identifier: TYGH111061
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer; Lung Cancer Metastatic

Keywords

Photodynamic Therapy; Peripheral Lung Cancer; Trans-Bronchoscope Ablation

Outcome Measures

Primary Outcomes (2)

• Technical Feasibility

  Number of times photodynamic therapy was delivered into the tumor using navigational bronchoscopy for each subject

  3 days

• Technical Safety

  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.

  6 months

Secondary Outcomes (1)

• Tumor remission rate

  3 months

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Procedure: Transbronchial PDT peripheral lung tumor ablation

Interventions

Transbronchial PDT peripheral lung tumor ablation PROCEDURE

Transbronchial lung tumor ablation with Photodynamic therapy

Arm 1

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taoyuan General Hospital: lead

Study Sites (1)

Taoyuan General Hospital, Ministry of Health and Welfare

Taoyuan, 320, Taiwan

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yei San Hsieh

  Taoyuan General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yei San Hsieh

CONTACT

+886975061108; yeisanh@gmail.com

Shu-Hsing Cheng

CONTACT

886-3-3699721; tyghcrc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Thoracic Surgery Department

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 16, 2024
• Study Start: March 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: February 16, 2024

Record last verified: 2024-02

Locations

TW (1)