臨床研究等提出・公開システム

An Exploratory Clinical Study for the Development of the Detective Method for Microvessels Using Photoacoustic Imaging (ECS-DDMMV-PAI)

A Clinical Study to Visualize Microvessels Using Photoacoustic Imaging (CS-VMV-PAI)

Kishi Kazuo

Keio University School of Medicine (Keio University Hospital)

35 Shinanomachi, Shinjuku-ku, Tokyo

kkishi@a7.keio.jp

Suzuki Yushi

Keio University School of Medicine

35 Shinanomachi, Shinjuku-ku, Tokyo

+81-3-5363-3814

fi080150@keio.jp

Recruiting

Jan. 19, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

parallel assignment

basic science

1. Patients suspected to have lymphedema or abnormality of lymph vessels of the upper or lower limbs, who are at least 20 years of age at the time of obtaining consent or who are between 16 and 20 years of age with their parental consent, as determined by their doctor that in a condition without any problems participating in the research,
2. Healthy persons without mental illness, dementia, who are judged by the doctor in charge that in a condition without any problems participating in the research and who are at least 20 years old at the time of obtaining consent.
3. Patients without mental illness, dementia, nor suspicious lymphatic dysfunction, who have the possible condition influencing photoacoustic images and are at least 20 years of age at the time of obtaining consent or who are between 16 and 20 years of age with their parental consent, as determined by their doctor that in a condition 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 or parents' consent in the case of under 20 age participants 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.

Both

lymphedema of the extremities

photoacoustic imaging study (after subcutaneous injection of indocyanine green)

Lymphedema

Photoacoustic Techniques

D008209

D061088

Safety of photoacoustic imaging system

None

+81-3-5363-3503

Dec. 14, 2021

Yes

The image data obtained in this study may be provided to research collaborating institutions. In this case, information such as the ID of the research subject and the date and time of acquisition will be deleted and the data will be made unlinked and anonymous. When providing the data, we will use a portable HDD with a password or a network that can only be accessed by this researcher.

none