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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012251
Receipt No. R000014323
Scientific Title An exploratory study to developing breast cancer diagnostic method using wide viewing angle photoacoustic mammography.
Date of disclosure of the study information 2013/11/08
Last modified on 2020/03/18

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Basic information
Public title An exploratory study to developing breast cancer diagnostic method using wide viewing angle photoacoustic mammography.
Acronym An exploratory study of photoacoustic mammography
Scientific Title An exploratory study to developing breast cancer diagnostic method using wide viewing angle photoacoustic mammography.
Scientific Title:Acronym An exploratory study of 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 in breast cancer diagnosis by evaluating photoacoustic images using wide viewing angle photoacoustic mammography.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Photoacoustic images using wide viewing angle 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 have benign or malignant tumors within the breast
2. Patients whose performance status are 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 have taken photosensitizer for photodynamic therapy
2. Patients with cardiac pacemakers
3. Patients who are in poor general status
4. Patients who are pregnancy, suspicion of pregnancy, or lactating
5. Patients who are judged ineligible to enroll into this clinical study due to any reasons by the doctor
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Masakazu
Middle name
Last name Toi
Organization Graduate School of Medicine, Kyoto University
Division name Breast Surgery
Zip code 606-8507
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL 075-751-3660
Email toi@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Masahiro
Middle name
Last name Takada
Organization Kyoto University Hospital
Division name Breast Surgery
Zip code 606-8507
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL 075-751-3660
Homepage URL
Email masahiro@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 Japanese Governmental office
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 Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
Tel 075-753-4680
Email ethcom@kuhp.kyoto-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

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 08 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014323
Publication of results Published

Result
URL related to results and publications https://www.nature.com/articles/srep41970
Number of participants that the trial has enrolled 30
Results
This clinical study indicated that photoacoustic imaging system appears to be a promising tool for noninvasive analysis of human blood vessels and may contribute to improve cancer diagnosis.
Results date posted
2020 Year 03 Month 18 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2017 Year 02 Month 07 Day
Baseline Characteristics
<Inclusion criteria>
1. Patients who have benign or malignant tumors within the breast 
2. Patients whose performance status are 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
<Exclusion criteria>
1. Patients who have taken photosensitizer for photodynamic therapy 
2. Patients with cardiac pacemakers 
3. Patients who are in poor general status 
4. Patients who are pregnancy, suspicion of pregnancy, or lactating 
5. Patients who are judged ineligible to enroll into this clinical study due to any reasons by the doctor
Participant flow
After written informed consent was obtained from all patients, photoacoustic image scan was performed. 
They underwent routine radiological (MMG, US, and/or MRI) and/or histological diagnosis (core biopsy) prior to surgery. 
Adverse events
none
Outcome measures
Photoacoustic images using wide viewing angle photoacoustic mammography.

Frequency of adverse events of photoacoustic mammography
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 11 Month 08 Day
Date of IRB
2014 Year 02 Month 13 Day
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 11 Month 08 Day
Last modified on
2020 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014323

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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