UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023928 |
|---|---|
| Receipt number | R000027553 |
| Scientific Title | Study on the efficacy and sfety of breast diagnostic imaging equipment (microwave scattered field tomographic imaging machine-a) |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2022/09/12 10:28:25 |
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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
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
tkunihisa@gmail.com
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027553
