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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000030500
Receipt No. R000034808
Scientific Title An Exploratory Clinical Study for The Development of the Diagnostic Method for Lymphatic-vessel Lesions Using Photoacoustic Imaging
Date of disclosure of the study information 2017/12/25
Last modified on 2019/08/06

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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 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 Suspended
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
2019 Year 08 Month 06 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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