UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the utility of the photoacoustic imaging for superficial tissue and lesion: comparison with the ultrasonography
Acronym	Evaluation of the utility of the photoacoustic imaging for superficial tissue and lesion
Scientific Title	Evaluation of the utility of the photoacoustic imaging for superficial tissue and lesion: comparison with the ultrasonography
Scientific Title:Acronym	Evaluation of the utility of the photoacoustic imaging for superficial tissue and lesion
Region	Japan

Condition
Condition	superficial lesion
Classification by specialty	Dermatology Radiology Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the ability to depict superficial tissue and lesion with the photoacoustic imaging
Basic objectives2	Others
Basic objectives -Others	To explore the utility of the photoacoustic imaging for superficial lesion
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The subjective and objective evaluation of the photoacoustic imaging
Key secondary outcomes	1) The association between the photoacoustic images and other images except for conventional ultrasonography 2) The association between the the characteristics of the examinees and the photoacoustic images

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Conventional ultrasonography
Interventions/Control_2	Photoacoustic imaging device
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 or patients with superficial lesion, aged 20 years or older at the time of consent acquisition. 2) Subjects who have agreed to participate in this study from their own free will with document consents.
Key exclusion criteria	1. Pregnancy or possible pregnancy 2. The status of immunodeficiency due to neutropenia and so on. 3. Complications that make imaging difficult (e.g. inability to maintain the posture). 4. In cases where the research director or the attending physician judges that conducting this research is inappropriate (e.g. hemorrhage or effusion from superficial lesion).
Target sample size	120

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Masahiro Jinzaki
Organization	Keio University School of Medicine
Division name	Department of Radiology
Zip code
Address	35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan
TEL	03-3353-1977(+81-3-3353-1977)
Email	jinzaki@rad.med.keio.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Keiichi Narita
Organization	Keio University School of Medicine
Division name	Department of Radiology
Zip code
Address	35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan
TEL	03-3353-1977(+81-3-3353-1977)
Homepage URL
Email	narit@rad.med.keio.ac.jp

Sponsor
Institute	Department of Radiology, Keio University School of Medicine
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 02 Month 15 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	Completed
Date of protocol fixation	2018 Year 02 Month 08 Day
Date of IRB	2018 Year 02 Month 15 Day
Anticipated trial start date	2018 Year 02 Month 15 Day
Last follow-up date	2018 Year 03 Month 13 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 02 Month 15 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=R000035209