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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003406
Receipt No. R000004127
Scientific Title earch for developing the breast cancer diagnostic method using photoacoustic mammography
Date of disclosure of the study information 2010/04/01
Last modified on 2017/08/18

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Basic information
Public title earch for developing the breast cancer diagnostic method using photoacoustic mammography
Acronym Translational research of photoacoustic mammography
Scientific Title earch for developing the breast cancer diagnostic method using photoacoustic mammography
Scientific Title:Acronym Translational research of photoacoustic mammography
Region
Japan

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

Objectives
Narrative objectives1 Researching the imaging procedure of photoacoustic mammography system suitable for diagnosis of breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Photoacoustic image of photoacoustic mammography
Key secondary outcomes Frequency of adverse events of photoacoustic 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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Photoacoustic Mammography
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 1.Patients who are required work-up by other image diagnosis, and will undergo an tissue diagnosis. 2.Patients whose performance status is 0 or 1 3. Female patients who can agree to participate in this study of their own will, and aged 20 years and older at the time of informed consent.
Key exclusion criteria 1. Patients who will have any treatment except surgery after this clinical test
2. Patients who are pregnancy or suspicion of pregnancy 3. Patients who have taken photosensitizer for photodynamic therapy. 4. Patients with cardiac pacemaker 5.Patients with a breast implant. 6. Patients who are judged ineligible to enroll into this clinical study due to any reasons by the doctor



Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Toi
Organization Graduate School of Medicine Kyoto University
Division name Breast Surgery
Zip code
Address 54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL 075-751-3660
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tomoharu Sugie
Organization Graduate School of Medicine Kyoto University
Division name Breast Surgery
Zip code
Address 54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL 0757513660
Homepage URL
Email sugie@kuhp.kyoto-u.ac.jp

Sponsor
Institute Graduate School of Medicine Kyoto University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

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 京都大学病院(京都府)

Other administrative information
Date of disclosure of the study information
2010 Year 04 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 No longer recruiting
Date of protocol fixation
2010 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 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
2010 Year 03 Month 29 Day
Last modified on
2017 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004127

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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