Transbroncheal Novel PDT Peripheral Lung Tumor Ablation With 5-ALA

NCT06679712 | Not Yet Recruiting DMC

• 1 other identifier: TYGH113004
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Photodynamic therapy (PDT) involves the use of special light-sensitive drugs that are selectively absorbed by cancer cells. When exposed to a specific wavelength of light, these drugs are activated within the tumor cells, triggering a free radical reaction that destroys the cancer cells. Currently, PDT is used in the treatment of early-stage lung cancer in the central airways or for advanced tumors causing airway obstruction. With advancements in medical technology, electromagnetic navigation bronchoscopy (EMB) can now be employed in a hybrid operating room (Hybrid OR) under radiological guidance to direct photodynamic therapy fibers to the tumor site for light therapy. Our research team previously proposed a novel light transmission method, using Sodium Porfimer as the photosensitizer. In the Hybrid OR, electromagnetic navigation bronchoscopy was utilized to infuse Lipiodol into the bronchial tree, enhancing the illumination range through the optical fiber effect. Energy of 630 nm at 200 J/cm (400 mW/500 seconds) delivered through a 3 cm cylindrical laser fiber was deemed safe, with no significant acute complications observed. However, due to the low light dosage, the therapeutic outcome was suboptimal, although one case demonstrated tumor necrosis with no apparent damage to the surrounding lung tissue. A second-phase pilot clinical trial aimed at improving light energy and treatment coverage through a multi-session, multi-angle light exposure model is also proved this method is feasible and safe. In addition to Sodium Porfimer, other photosensitizers are approved for clinical use in photodynamic diagnosis and therapy. For example, 5-Aminolevulinic Acid (5-ALA) has been approved for the treatment of brain cancer surgery. Similar to Sodium Porfimer, 5-ALA is a precursor of heme, and in certain cells (such as cancer cells and reticuloendothelial tissues) where there is a deficiency of the enzyme ferrochelatase, administering large amounts of 5-ALA or Sodium Porfimer leads to the accumulation of Protoporphyrin IX (PpIX). PpIX is a photosensitizer, and when exposed to a specific wavelength of light, it generates oxygen free radicals that destroy cancer cells, thereby producing the therapeutic effect of PDT. We propose this clinical trial to explore the use of 5-ALA as a substitute for Sodium Porfimer in the novel PDT treatment of peripheral lung tumors. Compared to Sodium Porfimer, 5-ALA has the same therapeutic mechanism but a shorter half-life. It can be taken orally 2-4 hours before treatment, requires only one day of light protection post-procedure, and is more cost-effective. 5-ALA (Gliolan) has also been approved by the FDA for photodynamic diagnosis and treatment of brain cancer, and clinical trials in other cancers have demonstrated its safety and feasibility. This phase 0 pilot clinical study plans to recruit six patients with peripheral malignant lung tumors (tumor diameter ≤ 30 mm). 5-ALA (Gliolan) will be used as the photosensitizer, and in the hybrid operating room, electromagnetic navigation bronchoscopy will guide a catheter to the tumor site. Lipiodol (iodized poppy seed oil) will be infused to coat the tumor, enhancing the light exposure range. The first three subjects will undergo a single-session light exposure to assess the feasibility and safety of the procedure. The remaining three subjects will receive multi-session, multi-angle light exposure to further verify the safety and effectiveness of the treatment. The findings from these subjects will serve as a reference for light energy parameters for future phase I clinical trials.

Conditions

Lung Cancer - Non Small Cell; Lung Metastases From Any Primary

Keywords

Photodynamic therapy; Peripheral lung cancer; Transbroncheal Ablation

Outcome Measures

Primary Outcomes (1)

• Feasibility of Transbronchial PDT ablation for peripheral lung tumor

  The study will track the success rate of patients completing the planned treatment steps. Each subject will undergo electromagnetic navigation bronchoscopy (EMB) to guide the injection of Lipiodol and the placement of the light-exposure fiber. The study will record the number of attempts required to correctly position the fiber at the tumor site and the total treatment time for each patient.

  minutes

Study Arms (1)

Transbronchial PDT

EXPERIMENTAL

Procedure: Transbronchial PDT lung tumor ablation

Interventions

Transbronchial PDT lung tumor ablation PROCEDURE

Transbronchial photodynamic therapy ablation for peripheral lung cancer

Transbronchial PDT

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 with a pathological diagnosis of malignant lung tumors (including primary lung cancer and metastatic lung cancer) in advanced or terminal stages.
• Patients for whom first- or second-line standard treatments (surgery, radiation therapy, or chemotherapy/immunotherapy/targeted therapy) have failed or who are unsuitable for standard treatments.
• Tumor size of less than or equal to 3 cm, clearly visible and assessable on chest CT scans.
• Patients whose tumors are inoperable or for whom surgery is not suitable.
• Patients in good physical condition with an ECOG (Eastern Cooperative - -Oncology Group) performance status score of 0 to 2.
• Patients capable of providing informed consent and willing to undergo regular follow-up during the trial.

You may not qualify if:

• Diagnosis of small cell lung cancer or non-solid malignancy.
• Tumor located in the central part of the lung.
• Previous radiation therapy to the area intended for treatment.
• Abnormal blood chemistry values.
• Chemotherapy within the past 4 weeks.
• Tumor invasion into major blood vessels.
• Allergy to porphyrins, porphyrin-related metabolites, Lipiodol, or iodine-based contrast agents.
• Plans to undergo curative surgery for lung tumors within the next 90 days.
• Patients with ophthalmologic diseases who may require a slit-lamp eye examination within the next 30 days.
• Mental illness that prevents the patient from undergoing bronchoscopy.
• Pregnant or planning to become pregnant, breastfeeding, or planning to breastfeed within 6 months after the procedure.
• Photodynamic therapy within the past month.
• Severe kidney or liver disease with abnormal renal or hepatic function.
• Plans to participate in another cancer treatment clinical trial within 3 months post-procedure.
• Patients with AIDS.

Sponsors & Collaborators

• Taoyuan General Hospital: lead
• Taipei Veterans General Hospital, Taiwan: collaborator

Study Sites (1)

Taoyuan General Hospital

Taoyuan District, 330, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yei-San Hsieh, MD.

CONTACT

886-975061108; yeisanh@gmail.com

Yu-Chi Chiu, PhD

CONTACT

886-975520576; newchiuyuchi@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 Surgical Department

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: November 7, 2024
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 7, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TW (1)