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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000005513
Receipt No. R000006514
Scientific Title An exploratory study to evaluate primary systemic therapy in breast cancer using photoacoustic mammography
Date of disclosure of the study information 2011/04/29
Last modified on 2011/04/26

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Basic information
Public title An exploratory study to evaluate primary systemic therapy in breast cancer using photoacoustic mammography
Acronym An exploratory study on photoacoustic mammography
Scientific Title An exploratory study to evaluate primary systemic therapy in breast cancer using photoacoustic mammography
Scientific Title:Acronym An exploratory study on photoacoustic mammography
Region
Japan

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

Objectives
Narrative objectives1 To study clinical usefulness of photoacoustic mammography for assessing primary systemic therapy in breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Photoacoustic image of tumor response to primary systemic therapy
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
90 years-old >=
Gender Female
Key inclusion criteria 1. Breast cancer patients who will undergo primary systemic therapy or undergoing primary systemic therapy
2. Patients whose performance status are 0 or 1
3. Patients who can give consent in writing to participate in this study of their own will
Key exclusion criteria 1. Patients who have taken photosensitizer for photodynamic therapy
2. Patients with cardiac pacemakers
3. Patients with breast implants
4. Patients who are in poor general status
5. Patients who are pregnancy, suspicion of pregnancy, or lactating
6. Patients who are judged ineligible to enroll into this clinical study due to any reasons by the doctor
Target sample size 15

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 Toshiyuki Kitai
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
Homepage URL
Email kitait@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

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 29 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 Preinitiation
Date of protocol fixation
2011 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2012 Year 04 Month 01 Day
Date trial data considered complete
2012 Year 04 Month 01 Day
Date analysis concluded
2012 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 04 Month 26 Day
Last modified on
2011 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006514

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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