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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016922
Receipt No. R000019641
Scientific Title Clinical investigation of microwave mammography
Date of disclosure of the study information 2015/03/27
Last modified on 2019/01/25

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Basic information
Public title Clinical investigation of microwave
mammography
Acronym Clinical investigation of microwave
mammography
Scientific Title Clinical investigation of microwave
mammography
Scientific Title:Acronym Clinical investigation of microwave
mammography
Region
Japan

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

Objectives
Narrative objectives1 In order to develop the novel non-invasive
imaging diagnostic technology for breast
cancer, we evaluate the propagation
characteristics of weak microwave inside
breast. The incident microwave from the skin
of the breast propagates into the fatty tissue, and it comes back to the skin surface as a reflected microwave after it is scattered by the tissues which have different physicalproperties, such as ductus lactiferi, acino, foliole and cancers. These characteristics is investigated using small ultra-wide band antenna. The range of microwave frequency is from 50 MHz to 12 GHz, and the output power is set below 50 nW which is extremely weaker comparing to environmental electromagnetic wave and have no ill effects on the human body.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes 1, Evaluation of the ratio of contrast between
cancer tissue and surrounding one after the
image reconstruction (just after the clinical
testing)
2, Comparison of cancer-detecting sensitivity
between the other non-invasive imaging
diagnostic technologies such as X-ray
mammography, ultrasonic echo and magnetic
resonance imaging. (just after the clinical
testing)
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 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 twenty patients is measured by irradiating extremely weak electromagnetic wave below an environmental one. Implementation period is five months including the time for their recruits. 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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Targeted breast cancer patient should be defined as the people who satisfy all of the following conditions.
1, The patient is diagnosed with breast cancer by pathologic and imaging diagnosis.
2, The patient is women older than 20 years old.
3, The patient can maintain lying on one's back on the bed within about 20 minutes of clinical testing time.
4, The patient accept the clinical test and subscribe to the agreement.
Key exclusion criteria 1, There are external injuries which have not recovered completely on the breast surface.
2, The patient is pregnant or might be pregnant. The patient is in lactation period.
3, The patient is judged as an unqualified person for safe clinical testing by the principal investigator or the doctor in attendance.
Target sample size 20

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
2019 Year 01 Month 25 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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