A Clinical Study to Visualize Microvessels Using Photoacoustic Imaging

JRCT ID: jRCTs032210561

Registered date:19/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: lymphedema of the extremities
• Date of first enrollment: 07/04/2022
• Target sample size: 120
• Study type: Interventional
• Intervention(s): photoacoustic imaging study (after subcutaneous injection of indocyanine green)

Outcome(s)

• Primary Outcome: Safety of photoacoustic imaging system
• Secondary Outcome: None

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Kishi Kazuo
• Secondary Sponsor: Imanishi Nobuaki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development