UMIN-CTR Clinical Trial

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
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 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044423