UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Identification of sentinel lymph node with infrared fluorescence in lung cancer
Title of the study (Brief title)	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	Hiromitsu Takizawa
Organization	Institute of Biomedical Sciences, Tokushima University Graduate School
Division name	Department of Thoracic,Endocrine Surgery and Oncology
Address	18-15, 3tyoume, Kuramototyo, Tokushima city, Tokushima prefecture
TEL	088-633-7143
Email	h-takizawa@mbf.ocn.ne.jp

Public contact
Name of contact person	Hiromitsu Takizawa
Organization	Institute of Biomedical Sciences, Tokushima University Graduate School
Division name	Department of Thoracic,Endocrine Surgery and Oncology
Address	18-15, 3tyoume, Kuramototyo, Tokushima city, Tokushima prefecture
TEL	088-633-7143
Homepage URL
Email	h-takizawa@mbf.ocn.ne.jp

Sponsor
Institute	Institute of Biomedical Sciences, Tokushima University Graduate School
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028352