A Prospective Clinical Study for Evaluation of Safe Resection Margin in Breast Conserving Surgery
Overview
- Phase
- Phase 2
- Intervention
- indocyanine green
- Conditions
- Breast Cancer
- Sponsor
- National Cancer Center, Korea
- Enrollment
- 149
- Locations
- 1
- Primary Endpoint
- detection rate
- Last Updated
- 9 years ago
Overview
Brief 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:
- 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
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.
Investigators
So-Youn Jung
Medical Doctor
National Cancer Center, Korea
Eligibility 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
Arms & Interventions
indocyanine green
As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome. Intervention: Drug: indocyanine green
Intervention: indocyanine green
Outcomes
Primary Outcomes
detection rate
Time Frame: one day
after complete resection with intraoperative ultrasound confirmed the lesion
Secondary Outcomes
- determine the pathological stability(one day)