UMIN-CTR Clinical Trial

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

breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Graduate School of Science, Kobe University
Kenjiro Kimura research group

Institute

Department

Personal name

Organization

Ministry of Public Management, Home Affairs,
Posts and Telecommunications

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

03

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

03

Month

26

Day

Last modified on

2020

Year

09

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019641