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ENB and Photodynamic Therapy in the Treatment for Early Lung Cancer

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
super-D ENB guided-PDT
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Early lung cancer, Photodynamic therapy, ENB

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

super-D ENB guided-PDT

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

post-operative complication
defined as any deviation from the normal postoperative course
post-operative pulmonary function
the pulmonary function at 6, 12, and 24 months post-operation
overall survival
The time interval between enrollment and death

Full Information

First Posted
July 5, 2017
Last Updated
July 9, 2017
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03211078
Brief Title
ENB and Photodynamic Therapy in the Treatment for Early Lung Cancer
Official Title
The Application of Electro-magnetic Navigation Bronchoscopy (ENB) and Photodynamic Therapy in the Treatment for Early Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 14, 2016 (Actual)
Primary Completion Date
September 1, 2017 (Anticipated)
Study Completion Date
September 15, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Early lung cancer, Photodynamic therapy, ENB

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
super-D ENB guided-PDT
Arm Type
Experimental
Arm Description
To test the feasibility of super-D ENB guided-PDT to treat small lung cancer which cannot be eradicated through surgical resection.
Intervention Type
Procedure
Intervention Name(s)
super-D ENB guided-PDT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease-free survival
Description
The time interval between enrollment and the earliest onset of any of the following events,: tumor local recurrence , distant metastasis, and mortality
Time Frame
5 years
Secondary Outcome Measure Information:
Title
post-operative complication
Description
defined as any deviation from the normal postoperative course
Time Frame
3 month
Title
post-operative pulmonary function
Description
the pulmonary function at 6, 12, and 24 months post-operation
Time Frame
6, 12, and 24 months
Title
overall survival
Description
The time interval between enrollment and death
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Multiple small lung cancer which cannot be completely removed by surgical resection. Patient with small early lung cancer with diameter less than 1 cm and with high surgical risk precluding surgery. Patient with small early lung cancer with diameter less than 1 cm but unwilling to receive surgical intervention. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jang-Ming Lee, MD. PhD.
Email
jmlee@ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Peiwen Yang, PhD.
Email
pwy1210@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jang-Ming Lee, MD. PhD.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
State/Province
Zhongzheng Dist.
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jang-Ming Lee
Phone
886-972651439
Email
jmlee@ntu.edu.tw

12. IPD Sharing Statement

Learn more about this trial

ENB and Photodynamic Therapy in the Treatment for Early Lung Cancer

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