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

Phase 2

• Conditions: Breast cancer; breast cancer, axillary lymph node dissection, lymphedema, image-guided surgery, axillary reverse mappinga; Breast Neoplasms

• Registration Number: JPRN-jRCTs071200005
• Lead Sponsor: agayasu Takeshi

Brief Summary

ARM with indocyanine green could be safely performed and lymphatic vessels could be identified in all cases. If the main lymphatic vessels and ARM lymph nodes can be preserved, lymphedema development may be reduced.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-20
• Study Completion: 2023-03-31
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 15

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. incidence of lymphedema after induction of ARM compared with that before induction of ARM<br>2. evaluation of adverse events in CTCAE 5.0

Secondary Outcome Measures

Name	Time	Method
1. successful detecting rate of lymph ducts<br>2. number, diameter, intensity, and pattern of connection in lymph ducts<br>3. incidence of recurrence in axillary lymph nodes