UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005167
Receipt No. R000005997
Scientific Title Validation study on the clinical usefulness of the ICG fluoresence method for detecting sentinel lymph node in early breast cancer in comparion with the RI method
Date of disclosure of the study information 2011/03/15
Last modified on 2015/12/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Validation study on the clinical usefulness of the ICG fluoresence method for detecting sentinel lymph node in early breast cancer in comparion with the RI method
Acronym Direct comparison between ICG fluoresence and RI method for SLN biospy
Scientific Title Validation study on the clinical usefulness of the ICG fluoresence method for detecting sentinel lymph node in early breast cancer in comparion with the RI method
Scientific Title:Acronym Direct comparison between ICG fluoresence and RI method for SLN biospy
Region
Japan Asia(except Japan)

Condition
Condition early breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the diagnositic performance of SLN biospy using ICG fluorescence technique, prospective multicenter study is performed compared with RI method.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes sensitivity
Key secondary outcomes 1) identification rate of SLN 2)additive effect of ICG fluoresence method on RI method. 3) identificaiton rate of SLN before and after primary systemic therapy. 4) involvement in SLN and non SLN. 5) adverse event of ICG fluoresence method.

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
Device,equipment
Interventions/Control_1 Sentinel lymph node will be detected by ICG fluoresence method and RI mehod
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 Female
Key inclusion criteria 1)Early breast cancer patients without axillary involvement. 2)Patient who is to undergo SLN biopsy. 3) Written consent to join in this study has been obtained from the patient itself.
Key exclusion criteria 1)Patients who had surgical biopsy or operation on the axilla. 2)Patient who had history of alleragy against ICG reagent or iodine. 3)Pregnant or breast feeding. 4)Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size 840

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Toi
Organization Graduate School of Medicine, Kyoto University
Division name Breast Surgery
Zip code
Address 54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL 075-751-3660
Email toi@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoharu Sugie
Organization Graduate School of Medicine Kyoto University
Division name Breast Surgery
Zip code
Address 54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL 075-751-3660
Homepage URL
Email sugie@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization Hamamatsu Photonics
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 国立がんセンター中央病院(東京都)、昭和大学(東京都)、都立駒込病院(東京都)、北野病院(大阪府)、大阪医療センター(大阪府)

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2011 Year 03 Month 23 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
2013 Year 11 Month 01 Day
Date trial data considered complete
2014 Year 01 Month 15 Day
Date analysis concluded
2014 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 03 Month 01 Day
Last modified on
2015 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005997

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.