UMIN-CTR Clinical Trial

Basic information
Public title	An exploratory study on the visualization of trunk perforating arteries using a new photoacoustic imaging system
Acronym	An exploratory study on the visualization of trunk perforating arteries using a new photoacoustic imaging system
Scientific Title	An exploratory study on the visualization of trunk perforating arteries using a new photoacoustic imaging system
Scientific Title:Acronym	An exploratory study on the visualization of trunk perforating arteries using a new photoacoustic imaging system
Region	Japan

Condition
Condition	Healthy volunteer, breast cancer
Classification by specialty	Breast surgery Plastic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate appropriate imaging conditions and imaging processing settings for optimal visualization of trunk perforating arteries using a new photoacoustic imaging system and to evaluate diagnostic potential of the system by comparing with other imaging modalities
Basic objectives2	Others
Basic objectives -Others	Anatomical investigation
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Spatial resolution (full width at half maximum, FWHM), penetration depth limit
Key secondary outcomes	Anatomical findings (location, depth, direction and brunching pattern of perforators)

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	Male and Female
Key inclusion criteria	1. Healthy volunteers without vascular diseases or patients with breast cancer whose health condition does not limit the examination 2. Aged 20 years or older at the time of the informed consent
Key exclusion criteria	1. Pregnant and lactating women 2. People who takes photosensitizer for photodynamic therapy 3. People with a cardiac pacemaker 4. People with greater than or equal to class 4 (People with severe systemic disease that is a constant threat to life) in ASA-PS (American Society of Anesthesiologists physical status classification) 5. People who have any following complications Infections of the evaluation region Neurological diseases and orthopedic disorders in which it is impossible to keep sitting or standing position 6. People 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	50

Research contact person
Last name of lead principal investigator	1st name Masakazu, Susumu Middle name Last name Toi, Saito
Organization	Graduate School of Medicine Kyoto University
Division name	Department of Breast Surgery, Plastic and Reconstructive Surgery
Zip code	606-8507
Address	54 Kawaharacho, Syogoin, Sakyo-ku, Kyoto City
TEL	075-751-3613
Email	susumus@kuhp.kyoto-u.ac.jp

Public contact
1st name of contact person	1st name Hanako Middle name Last name Shimizu
Organization	Graduate School of Medicine Kyoto University
Division name	Department of Breast Surgery
Zip code	606-8507
Address	54 Kawaharacho, Syogoin, Sakyo-ku, Kyoto City
TEL	075-751-3660
Homepage URL
Email	hanako87@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Graduate School of Medicine Kyoto University, Department of Breast Surgery, Plastic and Reconstructive Surgery
Institute
Department

Funding Source
Organization	Cabinet Office (Japan)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Canon Inc. Hitachi, Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto University Hospital Ethics Committe
Address	Konoe-cho, Yoshida, Sakyo-ku, Kyoto, Japan
Tel	0757534680
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	2018 Year 06 Month 01 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	57
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	2018 Year 01 Month 05 Day
Date of IRB	2018 Year 03 Month 22 Day
Anticipated trial start date	2018 Year 03 Month 22 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	2018 Year 01 Month 22 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=R000035270