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

Study Overview
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Brief Summary
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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: As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.

Detailed Description
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: indocyanine green


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: indocyanine green<br>As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome. Intervention: Drug: indocyanine green | Drug: indocyanine green<br>* As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.<br>* Other names: Near-infrared fluorescence;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection rate | after complete resection with intraoperative ultrasound confirmed the lesion | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine the pathological stability | determine the pathological stability with biopsy results confirmed during surgery | one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Near-infrared fluorescence, Indocyanine green, ICG, breast cancer