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
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable lung-cancer
Started Oct 2016
Shorter than P25 for not_applicable lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 14, 2016
CompletedFirst Submitted
Initial submission to the registry
July 5, 2017
CompletedFirst Posted
Study publicly available on registry
July 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2017
CompletedJuly 12, 2017
July 1, 2017
11 months
July 5, 2017
July 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
post-operative complication
3 month
post-operative pulmonary function
6, 12, and 24 months
overall survival
5 years
Study Arms (1)
super-D ENB guided-PDT
EXPERIMENTALTo test the feasibility of super-D ENB guided-PDT to treat small lung cancer which cannot be eradicated through surgical resection.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \. Bleeding tendency. 2 .Poor cardiopulmonary function with intolerance to bronchoscopy examination.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Zhongzheng Dist., 100, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jang-Ming Lee, MD. PhD.
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2017
First Posted
July 7, 2017
Study Start
October 14, 2016
Primary Completion
September 1, 2017
Study Completion
September 15, 2017
Last Updated
July 12, 2017
Record last verified: 2017-07