UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Indocyanine green fluorescence lymphatic node mapping for gastric cancer
Title of the study (Brief title)	Indocyanine green fluorescence lymphatic node mapping for gastric cancer
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Surgery in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the feasibility of indocyanine green fluorescence imaging on gastric cancer surgery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	False negative rate of IGFI on pathological lymph node metastasis
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Lymphatic vessel imaging by indocyanine green fluorescence imaging
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient receiving gastrectomy at University of Tokyo Hospital, who meets the following criteria 1) Tumor diameter 40mm and smaller 2) age 20 years and older 3) PS(ECOG Performance status) 0 or 1 4) Preserved main organ function 5) Written Informed consent under patients will
Key exclusion criteria	1) Past history of hypersensitivity to indocyanine green 2) Past history of hypersensitivity to iodine 3) Under or with will of pregnancy 4) Nursing
Target sample size	100

Research contact person
Name of lead principal investigator	Seto Yasuyuki
Organization	Graduate school of Medicine, University of Tokyo Hospital
Division name	Gastrointestinal surgery
Address	7-3-1, Bunkyou-ku Hongou, Tokyo
TEL	03-3815-5411
Email	seto-tky@umin.ac.jp

Public contact
Name of contact person	Iwata Ryohei
Organization	Graduate school of Medicine, University of Tokyo Hospital
Division name	Gastrointestinal surgery
Address	7-3-1, Bunkyou-ku Hongou, Tokyo
TEL	03-3815-5411
Homepage URL
Email	IWATAR-SUR@h.u-tokyo.ac.jp

Sponsor
Institute	University of Tokyo
Institute
Department

Funding Source
Organization	University of Tokyo
Organization
Division
Category of Funding Organization	Other
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	2018 Year 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 03 Month 26 Day
Anticipated trial start date	2018 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	2018 Year 03 Month 02 Day
Last modified on	2018 Year 09 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036015