UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intraoperative detection of sentinel lymph nodes in lung cancer
Title of the study (Brief title)	Intraoperative detection of sentinel lymph nodes in lung cancer
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aims are to determine sentinel lymph node identification rate using indocyanine green fluorescence imaging system in patients with lung cancer and to evaluate the accuracy of sentinel lymph node for the presence of mediastino-hilar metastasis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	pathological examination of sentinel lymph node
Key secondary outcomes

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	Prevention
Type of intervention	Medicine
Interventions/Control_1	Indocyanine green
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	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	patients with lung cancer who undergo pulmonary resection and mediastinal lymph node dissection
Key exclusion criteria	patients with iodine allergy or pregnant women
Target sample size	20

Research contact person
Name of lead principal investigator	Masahiko Higashiyama
Organization	Osaka International Cancer Institute
Division name	Department of Thoracic Surgery
Address	3-1-69, Ootemae, Chuou-ku, Osaka
TEL	06-6945-1181
Email	higasiyama-ma@mc.pref.osaka.jp

Public contact
Name of contact person	Toshiteru Tokunaga
Organization	Osaka International Cancer Institute
Division name	Department of Thoracic Surgery
Address	3-1-69, Ootemae, Chuou-ku, Osaka
TEL	06-6945-1181
Homepage URL
Email	tokunaga4615@yahoo.co.jp

Sponsor
Institute	Osaka International Cancer Institute
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
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	2010 Year 01 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 01 Month 01 Day
Anticipated trial start date	2010 Year 01 Month 04 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	2010 Year 01 Month 14 Day
Last modified on	2018 Year 01 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003655