Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Benign Breast Neoplasm.

National Cancer Center (NCC)

Status: Completed

Conditions: Benign Breast Neoplasm

Study type: Observational

Funder types: Other

Identifiers

NCT02172989

NCC-1410202-1

Details and patient eligibility

About

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.

Full description

Indocyanine green, ICG (ICG-fluorescence)

• ICG is the most commonly used fluorophore which approve by FDA.
• NIR-F imaging with ICG could be used in various surgeries. For example, SLN mapping in breast cancer and localization of liver metastasis, especially superficial lesion
• Contains sodium iodide, patients who have history of allergy to iodides should be used as caution.

Nonpalpable benign brest lesion localization

• New method for the localization and resection of non-palpable breast lesions.
• The breast lesion was correctly localized, and the area of ICG corresponded well to the site of the lesions.

Enrollment: 20 patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• nonpalpable benign breast lesion ≤ 2cm in patients with breast cancer.
• patients who need breast biopsy as treatment for breast cancer.
• Eastern Cooperative Oncology Group Performance status 0 or 1
• consented patients with more than 20 years, less than 70 years

Exclusion criteria

• nonpalpable benign breast lesion ≥ 2cm in patients with breast cancer.
• pregnancy
• history of severe allergy to ICG(Indocyanine Green)
• iode hypersensitiveness