UMIN-CTR Clinical Trial

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
Last 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
Email	toi@kuhp.kyoto-u.ac.jp

Public contact
1st 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
Email	yoshiaki@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Graduate School of Medicine Kyoto University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025591