ENB and Photodynamic Therapy in the Treatment for Early Lung Cancer
|ClinicalTrials.gov Identifier: NCT03211078|
Recruitment Status : Unknown
Verified July 2017 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : July 7, 2017
Last Update Posted : July 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Procedure: super-D ENB guided-PDT||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Application of Electro-magnetic Navigation Bronchoscopy (ENB) and Photodynamic Therapy in the Treatment for Early Lung Cancer|
|Actual Study Start Date :||October 14, 2016|
|Estimated Primary Completion Date :||September 1, 2017|
|Estimated Study Completion Date :||September 15, 2017|
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.
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211078
|Contact: Jang-Ming Lee, MD. PhD.||email@example.com|
|Contact: Peiwen Yang, PhD.||firstname.lastname@example.org|
|National Taiwan University Hospital||Recruiting|
|Taipei, Zhongzheng Dist., Taiwan, 100|
|Contact: Jang-Ming Lee 886-972651439 email@example.com|
|Principal Investigator:||Jang-Ming Lee, MD. PhD.||National Taiwan University Hospital|