A Prospective Clinical Study for Evaluation of Safe Resection Margin in Breast Conserving Surgery in Breast Cancer

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer localization.

In this study, our hypothesis are as following:

1. As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.

2. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Korea

Criteria

Inclusion Criteria:

• nonpalpable breast tumor < 5cm in patients with breast cancer.

• consented patients with more than 18 years

• Eastern Cooperative Oncology Group Performance status 0 or 1

• patients who need breast biopsy as treatment for breast cancer.

Exclusion Criteria:

• nonpalpable breast tumor ≥ 5cm in patients with breast cancer.

• inflammatory cancer of breast or patients who need MRM

• pregnancy

• history of severe allergy to ICG(Indocyanine Green)

• iode hypersensitiveness