ENB and Photodynamic Therapy in the Treatment for Early Lung Cancer

The Application of Electro-magnetic Navigation Bronchoscopy (ENB) and Photodynamic Therapy in the Treatment for Early Lung Cancer

With the increased incidence of lung cancer and prevalence of low dose CT screening, treating of early lung cancer has becoming an important issue in the clinical practice of thoracic oncology. In this clinical study, the investigators will evaluate whether superDimension (superD) ENB (Electromagnetic navigation bronchoscopy) in combination with interstitial photodynamic therapy can provide the chance of tumor eradication.

Study Overview

• Status: Unknown
• Conditions: Lung Cancer
• Intervention / Treatment: Procedure: super-D ENB guided-PDT

Detailed Description

Lung cancer is the one the major cause of cancer death all over the world especially in Asia. The prevalence of low dose CT screening has made more patients of lung cancer treated in the early stage. The treatment of choice for of early lung cancer is surgical resection. However, several difficulties exist in surgery for treating early lung cancer. eg. Some presenting as multi-focal lesions, which cannot be completely eradicated by surgical resection.

Electromagnetic navigation bronchoscopy (ENB)（superDimension™ Navigation System, super-D ENB) is a novel technique, which uses an image guided localization system to direct steerable bronchoscopic tools to predetermined points within the bronchial tree. This technology allows improved access to peripheral lesions in particular.

Photodynamic therapy (PDT) has been adopted an effective treatment option for the central located lung cancer by using photosensitizer which is focally retained in the tumor leading to tumor-specific abrasion by irradiating with a certain wave-length of light. The most frequently used and commercially available photosensitizer for lung cancer is PDT with Photofrin under 623 nm red light irradiation. For the peripheral lung cancer which cannot be approached by bronchoscopy, interstitial PDT with the aids of CT guided catheter implantation has been adopted. However, there are potential disadvantages of such approach including 1) bleeding or hemothorax during CT-guided catheter implantation; 2) dislodging of the catheter after lung collapse in the procedure; 3) unable to treat other lesion after pneumothorax.

In the current proposal, the investigators use ENB in combination with PDT to handle to test the feasibility of super-D ENB guided-PDT to treat small lung cancer which cannot be eradicated through surgical resection.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Zhongzheng Dist.
    • Taipei, Zhongzheng Dist., Taiwan, 100
      • Recruiting
      • National Taiwan University Hospital
      • Contact: Jang-Ming Lee; Phone Number: 886-972651439; Email: jmlee@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Multiple small lung cancer which cannot be completely removed by surgical resection.
2. Patient with small early lung cancer with diameter less than 1 cm and with high surgical risk precluding surgery.
3. Patient with small early lung cancer with diameter less than 1 cm but unwilling to receive surgical intervention.
4. Age above 20 years old and who can do the bronchoscopy test

Exclusion Criteria:

1. Bleeding tendency. 2 .Poor cardiopulmonary function with intolerance to bronchoscopy examination.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: super-D ENB guided-PDT; To test the feasibility of super-D ENB guided-PDT to treat small lung cancer which cannot be eradicated through surgical resection.

Procedure: super-D ENB guided-PDT; PDT with super-D EBN localization will be given for treating the target lung lesion. Intrvenous photofrin (2mg/kg) will be given 48 hours before intervention. After localization of the tumor by ENB, a 630nm of light will be give for the lesion with the dosage of 2oo J/cm. Intravenous general anesthesia and endobronchial intubation will be performed under the whole procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival	The time interval between enrollment and the earliest onset of any of the following events,: tumor local recurrence , distant metastasis, and mortality	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-operative complication	defined as any deviation from the normal postoperative course	3 month
post-operative pulmonary function	the pulmonary function at 6, 12, and 24 months post-operation	6, 12, and 24 months
overall survival	The time interval between enrollment and death	5 years

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Jang-Ming Lee, MD. PhD., National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2016
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): September 15, 2017

Study Registration Dates

• First Submitted: July 5, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): July 12, 2017
• Last Update Submitted That Met QC Criteria: July 9, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Photodynamic therapy; Early lung cancer; ENB
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 201407063DINB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No