Microvessel detection test by photoacoustic imaging

JRCT ID: jRCT1061230019

Registered date:02/06/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Lymphedema
• Date of first enrollment: 13/06/2023
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Perform preoperative evaluation of vessels using photoacoustic imaging equipment

Outcome(s)

• Primary Outcome: Vessel detection sensitivity

Secondary Outcome

1. Concordance of detection by ICG examination, ultrasound imaging, photoacoustic imaging
2. Perform subgroup analysis for each imaging condition
3. Analyze the morphological characteristics and relationships of lymphatic vessels according to severity

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1.Patients who have been diagnosed with secondary lower extremity lymphedema after ovarian cancer or uterine cancer treatment and are scheduled to receive LVA treatment
2.Patients aged 18 years or older at the time of consent form acquisition
3.Patients who do not have mental illness or dementia, and who are judged by the principal investigator or co-investigator to be in good health to participate in the study.
4.Patients who have voluntarily given their written informed consent to participate in the study.

Exclude criteria

1.Patients who are allergic or suspected to be allergic to iodine (However, if they have a history of ICG administration after an episode suggestive of iodine allergy and have not developed allergic symptoms, this is not applicable.)
2.Patients who are pregnant or may be pregnant
3.Patients who are taking kosen therapeutic agents (Photofylline, etc.)
4.Patients who have experienced a vagal reflex
5. If the research subject's physical condition is hindered by taking the shooting position or taking the shooting posture, or if cellulitis is seriously injured, the research director or co-investigator determines that it is inappropriate to conduct this research.

Related Information

• Primary Sponsor: Koshima Isao
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development