UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015305 |
|---|---|
| Receipt number | R000017804 |
| Scientific Title | A phase I clinical study of new type mammography. |
| Date of disclosure of the study information | 2014/10/23 |
| Last modified on | 2015/07/15 14:19:39 |
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Basic information
Public title
A phase I clinical study of new type mammography.
Acronym
A study to investigate the characteristic of weak electric wave in the breast of living body.
Scientific Title
A phase I clinical study of new type mammography.
Scientific Title:Acronym
A study to investigate the characteristic of weak electric wave in the breast of living body.
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate the characteristic of weak electric wave in the breast of living body in order to develop a noninvasive imaging diagnostic technology.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Measure the reflected wave, which entered and scattered around within a breast and comes back, to know about the characteristics.
Key secondary outcomes
Analyze the received signals and reconstruct the tumor of the breast in three-dimensional images.
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
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 the pre-operative breast cancer patients.
Key exclusion criteria
Patients who do not agree with this study.
Patients who were deemed inappropriate by the attending physician.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seishi Kono |
Organization
Kobe university hospital
Division name
Breast Surgery
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku , Kobe-city, Hyogo-Prefecture
TEL
078-382-6302
seishik@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seishi Kono |
Organization
Kobe university hospital
Division name
Breast Surgery
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe-city, Hyogo-Prefecture
TEL
078-382-6302
Homepage URL
seishik@medkobe-u.ac.jp
Sponsor or person
Institute
Kobe university
Institute
Department
Personal name
Funding Source
Organization
Ministry of Internal Affairs and Communication
Strategic Information and Communications R&D Promotion Programme
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hyogo cancer center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
神戸大学病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 23 | 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
| 2015 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 01 | Day |
Last modified on
| 2015 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017804
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
