UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030500 |
|---|---|
| Receipt number | 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 | 2021/06/24 09:34:48 |
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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
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
jmrbx767@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
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)
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034808
