UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Pilot Study of Indocyanine Green based Fluorescence Imaging in Locally Advanced Rectal Cancer and Metastatic Lateral Lymph Nodes
Title of the study (Brief title)	ICG-Based Fluorescence Imaging for Detection of Metastatic Lateral Lymph Nodes of Rectal Cancer
Region	Japan

Condition
Condition	Rectal Cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the possibility to detect sentinel lateral lymph node(s) after Indocyanine Green injections around the tumor in patients with locally advanced rectal cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Identification rate of the sentinel lateral lymph node(s) by using ICG injections around the tumor in patients with locally advanced rectal cancer.
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	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Indocyanine Green injections around the tumor
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	Patients with histo-pathological diagnosis of rectal cancer. Lower edge of the tumor is located below perineal reflection. Preoperative examinations show curability by surgical resection. Signature information form and consent by the patient.
Key exclusion criteria	Enlarged or bulky lateral lymph node diameter over 1cm by preoperative imaging Distant metastasis by preoperative imaging
Target sample size	20

Research contact person
Name of lead principal investigator	Masayuki Ishii
Organization	Shinko Hospital
Division name	gastroenterological surgery division
Address	1-4-47 Wakinohama Chuo-ku Kobe
TEL	078-261-6711
Email	m.ishii0104@shinkohp.or.jp

Public contact
Name of contact person	Masayuki Ishii
Organization	Shinko Hospital
Division name	gastroenterological surgery division
Address	1-4-47 Wakinohama Chuo-ku Kobe
TEL	078-261-6711
Homepage URL
Email	m.ishii0104@shinkohp.or.jp

Sponsor
Institute	Shinko Hospital
Institute
Department

Funding Source
Organization	Shinko Hospital
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	2018 Year 06 Month 15 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 04 Month 22 Day
Anticipated trial start date	2016 Year 05 Month 22 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 06 Month 14 Day
Last modified on	2018 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036885