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ENB and Photodynamic Therapy in the Treatment for Early Lung Cancer

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT03211078
First received: July 5, 2017
Last updated: NA
Last verified: July 2017
History: No changes posted
  Purpose
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, we will evaluate whether superdimension (superD) ENB (Electromagnetic navigation bronchoscopy) in combination with interstitial photodynamic therapy can provide the chance of tumor eradication.

Condition Intervention
Lung Cancer Procedure: super-D ENB guided-PDT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: The Application of Electro-magnetic Navigation Bronchoscopy (ENB) and Photodynamic Therapy in the Treatment for Early Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

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


Secondary Outcome Measures:
  • post-operative complication [ Time Frame: 3 month ]
    defined as any deviation from the normal postoperative course

  • post-operative pulmonary function [ Time Frame: 6, 12, and 24 months ]
    the pulmonary function at 6, 12, and 24 months post-operation

  • overall survival [ Time Frame: 5 years ]
    The time interval between enrollment and death


Estimated Enrollment: 10
Actual Study Start Date: October 14, 2016
Estimated Study Completion Date: September 15, 2017
Estimated Primary Completion Date: September 1, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 phosensitizer 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 implantationhas 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, we will 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.

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211078

Contacts
Contact: Jang-Ming Lee, MD. PhD. jmlee@ntu.edu.tw
Contact: Peiwen Yang, PhD. pwy1210@gmail.com

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Zhongzheng Dist., Taiwan, 100
Contact: Jang-Ming Lee    886-972651439    jmlee@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jang-Ming Lee, MD. PhD. National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03211078     History of Changes
Other Study ID Numbers: 201407063DINB
Study First Received: July 5, 2017
Last Updated: July 5, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Taiwan University Hospital:
early lung cancer; photodynamic therapy; ENB

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 11, 2017