UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029688 |
|---|---|
| Receipt number | R000033761 |
| Scientific Title | Efficacy and safety of hookwire-guided sentinel lymph node biopsy for breast cancer using contrast enhanced ultrasonography with Sonazoid |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2020/04/27 17:28:56 |
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Basic information
Public title
Efficacy and safety of hookwire-guided sentinel lymph node biopsy for breast cancer using contrast enhanced ultrasonography with Sonazoid
Acronym
Hookwire-guided Sonazoid-positive sentinel lymph node biopsy for breast cancer
Scientific Title
Efficacy and safety of hookwire-guided sentinel lymph node biopsy for breast cancer using contrast enhanced ultrasonography with Sonazoid
Scientific Title:Acronym
Hookwire-guided Sonazoid-positive sentinel lymph node biopsy for breast cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of efficacy and safety of hookwire-guided sentinel lymph node biopsy using contrast enhanced ultrasound with Sonazoid
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance of the results between Sonazoid positive sentinel nodes and blue dye positive sentinel nodes
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 | Device,equipment |
Interventions/Control_1
Hookwire-guided sentinel lymph node biopsy using contrast enhanced ultrasound with Sonazoid
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
| 90 | years-old | > |
Gender
Female
Key inclusion criteria
cT1-3N0M0 breast cancer patients
performance status 0-1
20 years old <= and < 90 years old
informed consent has been obtained
Key exclusion criteria
egg allergy
asthma
during or possibility of pregnancy
It seems not eligible for the present study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Miyake |
Organization
Osaka University Graduate School of Medicine
Division name
Breast and Endocrine surgery
Zip code
565-0871
Address
2-2-E10 Yamada-oka, Suita city, Osaka Pref., Japan
TEL
06-6879-3772
t_miyake@onsurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Miyake |
Organization
Osaka University Graduate School of Medicine
Division name
Breast and Endocrine surgery
Zip code
565-0871
Address
2-2-E10 Yamada-oka, Suita city, Osaka Pref., Japan
TEL
06-6879-3772
Homepage URL
t_miyake@onsurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-2 Yamada-oka, Suita city, Osaka Pref., Japan
Tel
unknown
rinri@hp-crc.med.osaka-u.ac.jp
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
| 2017 | Year | 11 | Month | 01 | 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
63
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
| 2017 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 24 | Day |
Last modified on
| 2020 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033761
