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A Clinical Study to Visualize Microvessels Using Photoacoustic Imaging

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032210561
Enrollment
120
Registered
2022-01-19
Start date
2022-04-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lymphedema of the extremities Lymphedema

Interventions

photoacoustic imaging study (after subcutaneous injection of indocyanine green)

Sponsors

Kishi Kazuo
Lead Sponsor
Imanishi Nobuaki
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Safety of photoacoustic imaging system

Contacts

Public ContactYushi Suzuki

Keio University School of Medicine

fi080150@keio.jp+81-3-5363-3814

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026