UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022215 |
|---|---|
| Receipt number | R000025591 |
| Scientific Title | A study to evaluate diagnostic accuracy of photoacoustic imaging combined with ultrasound examination for breast cancer |
| Date of disclosure of the study information | 2016/05/06 |
| Last modified on | 2019/03/13 16:55:02 |
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Basic information
Public title
A study to evaluate diagnostic accuracy of photoacoustic imaging combined with ultrasound examination for breast cancer
Acronym
A study to evaluate diagnostic accuracy of photoacoustic imaging for breast cancer
Scientific Title
A study to evaluate diagnostic accuracy of photoacoustic imaging combined with ultrasound examination for breast cancer
Scientific Title:Acronym
A study to evaluate diagnostic accuracy of photoacoustic imaging for breast cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate diagnostic accuracy of photoacoustic imaging combined with ultrasound examination for breast cancer comparing with breast ultrasound examination only.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AUC, accuracy, sensitivity and specificity of photoacoustic imaging combined with ultrasound examination and breast ultrasound examination
Key secondary outcomes
Incidence of adverse events by using a photoacoustic imaging system.
(Final monitoring is conducted within 90 days after intervention)
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 Imaging
(Duration of the device use is for one day)
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 aged over 20 years and older at the time of informed consent
2. Patients who are scheduled for or underwent histopathological diagnosis (Fine-needle aspiration or core needle biopsy)
3. Patients diagnosed with non-mass like region or mass <= 30 mm in breast ultrasound examination
4. Patients who have agreed to participate in this study from their own free will with document consents
Key exclusion criteria
1. Pregnant and lactating patients
2. Patients who takes photosensitizer for photodynamic therapy
3. Patients with a cardiac pacemaker
4. Patients who are in poor general status
5. Patients who are judged ineligible to enroll into this clinical study by the investigator or the sub-investigators due to communication difficulty, limitations in taking examination position and other reasons
Target sample size
110
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
Department of Breast Surgery
Zip code
606-8507
Address
54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3660
toi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Matsumoto |
Organization
Kyoto University Hospital
Division name
Department of Breast Surgery
Zip code
606-8507
Address
54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3660
Homepage URL
yoshiaki@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Cabinet Office (Japan)
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 Hospital Ethics Committe
Address
Konoe-cho, Yoshida, Sakyo-ku, Kyoto, Japan
Tel
0757534680
chaya@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
| 2016 | Year | 05 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
110
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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2019 | 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
| 2016 | Year | 05 | Month | 06 | Day |
Last modified on
| 2019 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025591
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
