UMIN-CTR Clinical Trial

Basic information
Public title	Study on the efficacy and sfety of breast diagnostic imaging equipment (microwave scattered field tomographic imaging machine-a)
Acronym	Clinical investigation of microwave mammography
Scientific Title	Study on the efficacy and sfety of breast diagnostic imaging equipment (microwave scattered field tomographic imaging machine-a)
Scientific Title:Acronym	Clinical investigation of microwave mammography
Region	Japan

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

Objectives
Narrative objectives1	Investigate the efficacy and safety of a new non-invasive imaging diagnostic equipment using microwave.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluating the efficacy of images obtained by new diagnostic equipment using microwave
Key secondary outcomes	Evaluating the safety of the new diagnostic equipment using microwave

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Put the UWB(ultra wide band) sensor on the surface of the breast and then the wave is transmitted and received. The data is analyzed and image is built by the computer.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Ipsilateral and contralateral breast of breast cancer patient. Both breast of healthy person.
Key exclusion criteria	Patients who do not agree with this study. Patients who were deemed inappropriate by the attending physician.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Tomonari Middle name Last name Kunihisa
Organization	Kobe university hospital
Division name	Breast Surgery
Zip code	6500017
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe-city, Hyogo-Prefecture
TEL	078-382-6871
Email	kunihisa@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Tomonari Middle name Last name Kunihisa
Organization	Kobe university hospital
Division name	Breast Surgery
Zip code	6500017
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe-city, Hyogo-Prefecture
TEL	078-382-6871
Homepage URL
Email	tkunihisa@gmail.com

Sponsor
Institute	Kobe University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kobe University hospital research ethics committee
Address	7-5-2 Kusunoki-chou, Tyuuou-ku, Kobe city, Hyogo prefecture
Tel	078-382-5111
Email	kainyu@med.kobe-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	神戸大学医学部附属病院（兵庫県）（Kobe university hospital, Hyogo）, 兵庫県立がんセンタ-(兵庫県)（Hyogo cancer center, Hyogo）, ときわ病院（兵庫県）（Tokiwa Hospital, Hyogo）,岡本クリニック（兵庫県）（Okamoto Clinic, Hyogo）、レディースクリニックやぎ（大阪府）（Lady's clinic Yagi, Osaka）、医療法人社団　大地の会　KRD　Nihombashi(東京都)（Medical corporation corporation　Daichinokai KRD Nihonbashi）、慶應義塾大学医学部（東京都）(Keio University School of Medicine)

Other administrative information
Date of disclosure of the study information	2016 Year 10 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	2016 Year 08 Month 19 Day
Date of IRB	2020 Year 08 Month 25 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2024 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 09 Month 04 Day
Last modified on	2022 Year 09 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027553