Feasibility Study of Using Navigational Bronchoscopy to Perform PDT-Photofrin® in Unresectable Peripheral Lung Cancer

Official Title

A Multicentre, Prospective, Open-label, Single-arm Clinical Study of the Safety and Feasibility of Using Navigational Bronchoscopy to Perform Interstitial Photodynamic Therapy Using Photofrin® as Treatment in Subjects With Unresectable Stage IA Peripheral Non-small Cell Lung Cancer (NSCLC)

Summary:

This research study is being conducted to assess the safety and feasibility of using a new developed bronchoscopic technology called electronavigational bronchoscopy to treat subjects with peripheral stage T1A non-small cell lung cancer (NSCLC), who are inoperable or refused surgery, and are not candidates or refused radiation therapy. It will involve 10 sites in USA and Canada. Participation will last 6 months.

Trial Description

Primary Outcome:

  • Feasibility to perform PDT into tumour
Secondary Outcome:
  • Tumour response
  • Change from baseline in performance status on the Eastern Cooperative Oncology Group (ECOG) score
  • Change from baseline in health-related quality of life on the Short Form (36) Health Survey (SF-36) score
  • Change from baseline in health-related quality of life on the 4- and 7-point EORTC QLQ-C30
  • Change from baseline in health-related quality of life on the 4- point EORTC QLQ-LC13
  • Proportion of patients with serious and non-serious adverse events
  • Immunology markers concentrations
Lung cancer accounts for almost one-third of cancer deaths. Cancer screening strategies have the potential to achieve a 20% reduction in death rates. Newly developed bronchoscopic technologies (such as navigational bronchoscopy) have shown to enable physicians to safely reach lesions in peripheral regions of the lung and obtain diagnosis. This new technology may now potentially offer bronchoscopic therapeutic interventions, such as photodynamic therapy, to tumours that were previously unreachable due to their peripheral anatomic location.

Photodynamic therapy (PDT) uses a combination of a photosensitizing drug (a drug that is activated by light), called porfimer sodium (Photofrin®), and a light from a laser that emits no heat. This technique works to allow the medical doctor to specifically target and destroy abnormal or cancer cells while limiting damage to surrounding healthy tissue. The activation of the drug is done by lighting the abnormal area using a fiber optic device (very fine fiber [like a fishing line] that permits light transmission) inserted into a flexible tube called bronchoscope. The light activates the porfimer sodium, which is concentrated in the abnormal tissue, leading to its destruction.

The purpose of this study is to determine if physicians can reach the tumours in the periphery of the lung via electronavigational bronchoscopy and deliver the photodynamic therapy by placing the optical fiber into the tumour.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society