Validation of safety and efficacy for Axillary Reverse Mapping (ARM)

JRCT ID: jRCTs071200005

Registered date:20/04/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 02/06/2020
• Target sample size: 15
• Study type: Interventional
• Intervention(s): Off-label use of ICG

Outcome(s)

Primary Outcome

1. incidence of lymphedema after induction of ARM compared with that before induction of ARM
2. evaluation of adverse events in CTCAE 5.0

Secondary Outcome

1. successful detecting rate of lymph ducts
2. number, diameter, intensity, and pattern of connection in lymph ducts
3. incidence of recurrence in axillary lymph nodes

Key inclusion & exclusion criteria

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

Include criteria

1. age: over 20 year-old at an informed consent
2. gender: unmentioned
3. patients diagnosed as positive in axillary lymph nodes before surgery and positive in sentinel lymph nodes during surgery
4. Neoadjuvant chemotherapy: unmentioned
5. patients with a witten informed consent and good comprehension after enough explanation about this study

Exclude criteria

1. patients who had developed lymph edema before surgery
2. patients with severe liver dysfunction
3. patients with past history of allergy for the indocyanine green and iodine
4. pregnent patients
5. patients who undergo bilateral axillary lymph node dissection
6. other patients who were judged as inappropriate by the chief physician for this study

Related Information

• Primary Sponsor: Nagayasu Takeshi
• Secondary Sponsor: Otsubo Ryota