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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032986
Receipt No. R000036885
Scientific Title A Pilot Study of Indocyanine Green based Fluorescence Imaging in Locally Advanced Rectal Cancer and Metastatic Lateral Lymph Nodes
Date of disclosure of the study information 2018/06/15
Last modified on 2018/06/14

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Basic information
Public title A Pilot Study of Indocyanine Green based Fluorescence Imaging in Locally Advanced Rectal Cancer and Metastatic Lateral Lymph Nodes
Acronym ICG-Based Fluorescence Imaging for Detection of Metastatic Lateral Lymph Nodes of Rectal Cancer
Scientific Title A Pilot Study of Indocyanine Green based Fluorescence Imaging in Locally Advanced Rectal Cancer and Metastatic Lateral Lymph Nodes
Scientific Title:Acronym 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
1st name
Middle name
Last name Masayuki Ishii
Organization Shinko Hospital
Division name gastroenterological surgery division
Zip code
Address 1-4-47 Wakinohama Chuo-ku Kobe
TEL 078-261-6711
Email m.ishii0104@shinkohp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Ishii
Organization Shinko Hospital
Division name gastroenterological surgery division
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Open public recruiting
Date of protocol fixation
2016 Year 04 Month 22 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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