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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038953
Receipt No. R000044420
Scientific Title Examination on characteristics and usefulness of DWIBS.
Date of disclosure of the study information 2020/01/01
Last modified on 2019/12/22

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Basic information
Public title Examination on characteristics and usefulness of DWIBS.
Acronym Examination on characteristics and usefulness of DWIBS.
Scientific Title Examination on characteristics and usefulness of DWIBS.
Scientific Title:Acronym Examination on characteristics and usefulness of DWIBS.
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Examine the depiction output of metastatic lesions of breast cancer of DWIBS compared with contrast-enhanced CT.
Basic objectives2 Others
Basic objectives -Others Compare the ability of DWIBS to evaluate the therapeutic effect on metastatic breast cancer lesions with contrast-enhanced CT.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The ability of DWIBS to depict metastatic lesions of breast cancer compared with contrast-enhanced CT examination.
Key secondary outcomes Ability to evaluate the therapeutic effect of DWIBS on metastatic lesions of breast cancer.

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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Add DWIBS to contrast CT for breast cancer metastasis search.
Add DWIBS to contrast-enhanced CT to evaluate the therapeutic effect on metastatic lesions of breast cancer.
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 Male and Female
Key inclusion criteria Cases diagnosed as breast cancer, for which both contrast-enhanced CT and DWIBS can be performed as a metastasis search.
Key exclusion criteria Cases where both enhanced CT and DWIBS cannot be performed.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Shinsaku
Middle name
Last name KANAZAWA
Organization SUNKOKAI KOGA Hospital
Division name Breast Surgery
Zip code 425-0088
Address 2-30-1, Daikakuji, Yaizu-shi, Shizuoka
TEL 0546285500
Email shikanazawa-gi@umin.net

Public contact
Name of contact person
1st name Shinsaku
Middle name
Last name KANAZAWA
Organization SUNKOKAI KOGA Hospital
Division name Breast Surgery
Zip code 425-0088
Address 2-30-1, Daikakuji, Yaizu-shi, Shizuoka
TEL 0546285500
Homepage URL
Email shikanazawa-gi@umin.net

Sponsor
Institute SUNKOKAI KOGA Hospital
Institute
Department

Funding Source
Organization SUNKOKAI KOGA Hospital
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 SUNKOKAI KOGA Hospital
Address 2-30-1, Daikakuji, Yaizu-shi, Shizuoka
Tel 0546285500
Email shikanazawa-gi@umin.net

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
2020 Year 01 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
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
2019 Year 12 Month 08 Day
Date of IRB
2019 Year 12 Month 20 Day
Anticipated trial start date
2019 Year 12 Month 08 Day
Last follow-up date
2023 Year 12 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
2019 Year 12 Month 22 Day
Last modified on
2019 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044420

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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