UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038954 |
|---|---|
| Receipt number | R000044423 |
| Scientific Title | Study on characteristics and usefulness of breast DWI. |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2019/12/22 22:12:32 |
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Basic information
Public title
Study on characteristics and usefulness of breast DWI.
Acronym
Study on characteristics and usefulness of breast DWI.
Scientific Title
Study on characteristics and usefulness of breast DWI.
Scientific Title:Acronym
Study on characteristics and usefulness of breast DWI.
Region
| Japan |
Condition
Condition
Breast lesions
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Non-contrast MRI DWI images are expected to be a noninvasive screening test for breast cancer high-risk groups, but are known to have low lesion delineation output.
In this study, we examine the features and usefulness of DWI imaging by examining cases in which histological examination was performed for mammography MRI and breast lesions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the differential diagnostic ability of DWI images for benign or malignant breast lesions.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1. Cases who have undergone contrast-enhanced MRI and have confirmed histopathological diagnosis.
2. Patients who did not refuse inclusion in this clinical trial.
Key exclusion criteria
1. Patients without contrast-enhanced MRI or clinicopathological diagnosis.
2. Patients who refused to be included in this clinical trial.
Target sample size
150
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
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
shikanazawa-gi@umin.net
Sponsor or person
Institute
SUNKOKAI KOGA Hospital
Institute
Department
Personal name
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
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 | 03 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 12 | Month | 22 | Day |
Last modified on
| 2019 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044423
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
