A Clinical Study to Visualize Lymph Vessels Using Photoacoustic Imaging

JRCT ID: jRCTs032180204

Registered date:07/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: lymphedema of the extremities
• Date of first enrollment: 10/03/2018
• Target sample size: 300
• Study type: Interventional
• Intervention(s): photoacoustic imaging study (after subcutaneous injection of indocyanine green)

Outcome(s)

• Primary Outcome: The capability of the photoacoustic imaging system for visualizing the lymph-vessel lesion of the patients

Secondary Outcome

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.
3. The relationship between the conditions at the examination and the photoacoustic images.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

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
• Secondary ID(s): -