UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of microwave mammography
Title of the study (Brief title)	Microwave mammography
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the microwave mammography in the breast cancer imaging diagnosis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To diagnose tiny breast cancer, 4-6 mm in diameter
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Microwave mammography for diagnostic modality
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	Not applicable
Gender	Female
Key inclusion criteria	Breast cancer patient
Key exclusion criteria	Not in paticular
Target sample size	50

Research contact person
Name of lead principal investigator	Kimihito Fujii
Organization	Aichi Medical University
Division name	Division of Breast and Endocrine Surgery
Address	1-1, Yazakokarimata, Ngakute-city
TEL	0561-62-3311
Email	kfujii@aichi-med-u.ac.jp

Public contact
Name of contact person	Kimihito Fujii
Organization	Aichi Medical University
Division name	Division of Breast and Endocrine Surgery
Address	1-1, Yazakokarimata, Ngakute-city
TEL	0561-62-3311
Homepage URL
Email	kfujii@aichi-med-u.ac.jp

Sponsor
Institute	Aichi Medical University
Institute
Department

Funding Source
Organization	Aichi Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Shizuoka University
Name of secondary funｄer(s)

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	2018 Year 06 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 04 Month 09 Day
Anticipated trial start date	2018 Year 04 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 05 Month 28 Day
Last modified on	2018 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037347