UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	earch for developing the breast cancer diagnostic method using photoacoustic mammography
Title of the study (Brief title)	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	Masakazu Toi
Organization	Graduate School of Medicine Kyoto University
Division name	Breast Surgery
Address	54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL	075-751-3660
Email

Public contact
Name of contact person	Tomoharu Sugie
Organization	Graduate School of Medicine Kyoto University
Division name	Breast Surgery
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.

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2010 Year 03 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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