UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005167 |
|---|---|
| Receipt number | 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 18:52:57 |
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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
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
sugie@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005997
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