UMIN-CTR Clinical Trial

Basic information
Public title	Research on the effectiveness and safety of microwave mammography
Acronym	Research on the effectiveness and safety of microwave mammography
Scientific Title	Research on the effectiveness and safety of breast imaging diagnostic equipment (Microwave scattering field tomography imaging system)
Scientific Title:Acronym	Research on the effectiveness and safety of breast imaging diagnostic equipment (Microwave scattering field tomography imaging system)
Region	Japan

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

Objectives
Narrative objectives1	In this study, we will confirm the ability to visualize the intramammary structure on microwave mammography images and clarify its usefulness in diagnosis. In addition, we will investigate the effects of weak microwaves on living organisms and evaluate their safety.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Drawability (Efficacy) of microwave mammography image by microwave mammography device.
Key secondary outcomes	1. We evaluate the safety from the viewpoint of the thermal action of the breast imaging diagnostic apparatus. 2. We evaluate the safety and usefulness of the protective seal. 3. Compared with X-ray mammography images, ultrasonic examination images, MRI examination images, etc., we evaluate the imaging ability of microwave mammography.

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	Electromagnetic wave from breast cancer of person is measured by irradiating extremely weak electromagnetic wave below an environmental one. The strength of adopted electromagnetic wave is one digit smaller than one of wireless LAN device, and testing time required is within 30 minutes.
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Selection criteria for cancer patients 1) Breast cancer is suspected by imaging diagnosis or diagnosed as breast cancer by pathological diagnosis. 2) Regardless of sex, over 16 years old. 3) It is possible to maintain the supine state on the bed during the examination of about 20 minutes. 4) Regarding research participation, written informed consent was obtained from the subject himself. In the case of an underage, written informed consent has been obtained from parents. Selection criteria for healthy person 1) Breast cancer is not suspected by diagnostic imaging . 2) Regardless of sex, over 16 years old. 3) It is possible to maintain the supine state on the bed during the examination of about 20 minutes. 4) Regarding research participation, written informed consent was obtained from the subject himself. In the case of an underage, written informed consent has been obtained from parents.
Key exclusion criteria	1) There is a trauma that is not cured on the breast surface. 2) In addition, the subject who judged it though a study responsibility doctor or the medical attendant carried out this study safely if inadequate.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kenjiro Kimura
Organization	Kobe University
Division name	Graduate School of Science
Zip code
Address	1-1 Rokkodai-cho, Nada-ku, Kobe 657-8501
TEL	078-803-5702
Email	kimura@gold.kobe-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kenjiro Kimura
Organization	Kobe University
Division name	Graduate School of Science
Zip code
Address	1-1 Rokkodai-cho, Nada-ku, Kobe 657-8501
TEL	078-803-5702
Homepage URL
Email	kimura@gold.kobe-u.ac.jp

Sponsor
Institute	Graduate School of Science, Kobe University Kenjiro Kimura research group
Institute
Department

Funding Source
Organization	Ministry of Public Management, Home Affairs, Posts and Telecommunications
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2015 Year 03 Month 27 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	Completed
Date of protocol fixation	2014 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date	2015 Year 04 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 03 Month 26 Day
Last modified on	2020 Year 09 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019641