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

Completed

• Conditions: Benign Breast Neoplasm

• Registration Number: NCT02172989
• Lead Sponsor: National Cancer Center, Korea

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:

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-23
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-24
• Primary Completion: 2015-04
• Study Completion: 2015-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-17
• Last Update Posted: 2015-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
non-palpable lesion localization rate	up to 6month	non-palpable lesion localization rate = number of patients complete excision of lesion / 20 enrolled patients

Secondary Outcome Measures

Name	Time	Method
lesion of resection size, completeness of resection	up to 6month	actual lesion of width\*height\*length / resection lesion of width\*height\*length

Trial Locations

Locations (1)

National Cancer Center; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of