UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003406 |
|---|---|
| Receipt number | 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 14:47:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
sugie@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
