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

National Cancer Center (NCC)

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Drug: indocyanine green

Study type: Interventional

Funder types: Other

Identifiers

NCT02817334

NCC-1410202-3

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: 149 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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149 participants in 1 patient group

indocyanine green

Experimental group

Description:

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

Treatment:

Drug: indocyanine green