An Exploratory Clinical Study for The Development of the Diagnostic Method for Lymphatic-vessel Lesions Using Photoacoustic Imaging - ECS-DDMLL-PAI

Kishi Kazuo0 sites71 target enrollmentMarch 7, 2019

Overview

Photoacoustic imaging was suggested to be useful as an imaging test for lymphatic vessels.

Registry

who.int

Start Date

March 7, 2019

End Date

March 6, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Kishi Kazuo

•1\. Patients aged 20 years or older at the time of consent acquisition and suspected to have lymphedema or abnormality of lymph vessels of the upper or 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\. Patients aged 20 years or older at the time of consent acquisition without mental illness, dementia, nor suspicious lymphatic dysfunction, who have the possible condition influencing photoacoustic images and are judged by the doctor in charge without any problems participating in the research.
•4\. Persons in accordance with criteria 1, 2 or 3 who have agreed to participate in this study from their own free will with document consents.

•1\. Allergy or possible allergy to local anesthetics (however, those who are not to be used anesthetics in
•this study are not excluded).
•2\. Allergy or possible allergy to iodine (however, those who did not show allergic reaction with the use of indocyanine green (ICG) after the episode of suspicious iodine allergy are not excluded in this study. Also, those who are not to be injected ICG in this study are not excluded).
•3\. Pregnancy or possible pregnancy
•4\. The status of immunodeficiency due to neutropenia and so on.
•5\. Complications that make imaging difficult (e.g. inability to maintain the posture).
•6\. 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).
•7\. Past history or complication associated with lymphatic flow in the upper or lower extremities in
•healthy subjects.