UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026155 |
|---|---|
| Receipt number | R000028352 |
| Scientific Title | Identification of sentinel lymph node with infrared fluorescence in lung cancer |
| Date of disclosure of the study information | 2017/03/21 |
| Last modified on | 2017/02/15 22:58:24 |
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Basic information
Public title
Identification of sentinel lymph node with infrared fluorescence in lung cancer
Acronym
Identification of sentinel lymph node in lung cancer
Scientific Title
Identification of sentinel lymph node with infrared fluorescence in lung cancer
Scientific Title:Acronym
Identification of sentinel lymph node in lung cancer
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify sentinel lymph node and lymph flow in lung cancer, we will inject 0.5ml (5mg/ml) of ICG(Diagnogreen) to the normal lung parenchyma around clinical stage I lung cancer, and observate it by fluorescence endoscopic system. The identification rate of sentinel lymph node is analysed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint is to assess sensitivity and specificity of sentinel lymph node identification. Standard operation for lung cancer (lobectomy and lymph node dissection) would be performed, and compare metastatic status of sentinel lymph node with that of the other mediastinal lymph node by postoperative histopathological examination.
Key secondary outcomes
To assess adverse effect for local injection of ICG.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
When we would reach thoracic cavity at usual lung cancer operation, we identify the location of tumors. we would inject 0.5ml of ICG to the normal lung parenchyma around tumor.Sentinel lymph node would be identified, to observe lymph node and lymph flow in lung cancer by fluorescence endoscopic system. Mediastinal lymph node dissection including this sentinel lymph node would be performed as usual as standard lung cancer surgery.
Postoperative histopathological examination showed the metastatic sentinel lymph node or not.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
primary lung cancer patient with clinical stage I according to preoperative examination.
Key exclusion criteria
The patient without tolerance for segmentectomy.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Takizawa |
Organization
Institute of Biomedical Sciences, Tokushima University Graduate School
Division name
Department of Thoracic,Endocrine Surgery and Oncology
Zip code
Address
18-15, 3tyoume, Kuramototyo, Tokushima city, Tokushima prefecture
TEL
088-633-7143
h-takizawa@mbf.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Takizawa |
Organization
Institute of Biomedical Sciences, Tokushima University Graduate School
Division name
Department of Thoracic,Endocrine Surgery and Oncology
Zip code
Address
18-15, 3tyoume, Kuramototyo, Tokushima city, Tokushima prefecture
TEL
088-633-7143
Homepage URL
h-takizawa@mbf.ocn.ne.jp
Sponsor or person
Institute
Institute of Biomedical Sciences, Tokushima University Graduate School
Institute
Department
Personal name
Funding Source
Organization
japan society for the promotion of science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2017 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 15 | Day |
Last modified on
| 2017 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028352
