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

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 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)

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

Value
https://center6.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