NCT02817334

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 149 (estimated)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Breast Cancer

Interventions

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

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-09-01
• Completion: 2016-12-01
• First posted: 2016-06-29
• Last updated: 2016-06-29

Locations

1 site across 1 country: South Korea