UMIN-CTR Clinical Trial

Basic information
Public title	An Exploratory Clinical Study for The Development of the Diagnostic Method for Lymphatic-vessel Lesions Using Photoacoustic Imaging
Acronym	A Clinical Study to Visualize Lymph Vessels Using Photoacoustic Imaging
Scientific Title	An Exploratory Clinical Study for The Development of the Diagnostic Method for Lymphatic-vessel Lesions Using Photoacoustic Imaging
Scientific Title:Acronym	A Clinical Study to Visualize Lymph Vessels Using Photoacoustic Imaging
Region	Japan

Condition
Condition	lymphedema
Classification by specialty	Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate visualizing capacity of photoacoustic imaging for lymph-vessel lesions of the limbs, and clarify the usefulness for diagnosis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The capability of the photoacoustic imaging system for visualizing the lymph-vessel lesion of the patients
Key secondary outcomes	1. The relationship between the photoacoustic images and the images by other modalities 2. The relationship between the characteristics of the examinees and the photoacoustic images.

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	After subcutaneous injection of indocyanine green in the dorsum of foot, photoacoustic imaging is taken. (The amount of indocyanine green used is up to 5 mg, and the 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. Patients aged 20 years or older at the time of consent acquisition and suspected to have lymphedema of the lower limbs, who are judged by their doctor that in a condition without any problems participating in the research. 2. Healthy persons aged 20 years or older at the time of consent acquisition without mental illness, dementia, who are judged by the doctor in charge that in a condition without any problems participating in the research. 3. Pearsons in accordance with criteria 1 or 2 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 it is judged by the research director or the attending physician that it is inappropriate for carrying out this research (e.g. having trouble with the subject's physical condition by keeping the posture during the imaging).
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name Kishi
Organization	Keio University School of Medicine
Division name	Department of Plastic and Reconstructive Surgery
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ward, Tokyo 160-8582, Japan
TEL	03-5363-3814
Email	kkishi@a7.keio.jp

Public contact
Name of contact person	1st name Hiroki Middle name Last name Kajita
Organization	Keio University School of Medicine
Division name	Department of Plastic and Reconstructive Surgery
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ward, Tokyo 160-8582, Japan
TEL	03-3352-1524
Homepage URL
Email	jmrbx767@keio.jp

Sponsor
Institute	Keio University
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	Canon Inc.
Name of secondary funder(s)	Canon Inc. Hitachi, Ltd.

IRB Contact (For public release)
Organization	Keio University School of Medicine Ethics Committee
Address	35 Shinanomachi, Shinjuku-ward, Tokyo 160-8582, Japan
Tel	03-3353-1211 (62014)
Email	med-rinri-jimu@adst.keio.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	jRCTs032180204
Org. issuing International ID_1	jRCT
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	慶應義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 25 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	71
Results	Regarding the scientific validity, the lymphatic vessel images of healthy subjects and patients obtained by taking photoacoustic imaging were published in Radiology and Journal of Surgical Oncology. The finding of lymphatic pump were also published in Plastic and Reconstructive Surgery Global Open. In addition, the relationship between the lymphatic vessel images obtained by optical ultrasound imaging and the images obtained by ICG fluorescence lymphography was published in Radiology.
Results date posted	2021 Year 06 Month 24 Day
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	Main results already published
Date of protocol fixation	2017 Year 12 Month 20 Day
Date of IRB	2017 Year 12 Month 25 Day
Anticipated trial start date	2017 Year 12 Month 26 Day
Last follow-up date	2021 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	2017 Year 12 Month 21 Day
Last modified on	2021 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034808