Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Breast Cancer

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: indocyanine green

• Registration Number: NCT02473159
• 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: 2015-03
• Study First Submitted: 2015-05-08
• Status Verified: 2015-06
• Study First Submitted QC: 2015-06-11
• Study First Posted: 2015-06-16
• Last Update Submitted: 2015-06-17
• Last Update Posted: 2015-06-18
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 5

Inclusion Criteria

• nonpalpable breast tumor ≤ 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 breast tumor ≥ 2cm in patients with breast cancer.
• pregnancy
• history of severe allergy to ICG(Indocyanine Green)
• iode hypersensitiveness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
detection rate	one day	after complete resection with intraoperative ultrasound confirmed the lesion

Secondary Outcome Measures

Name	Time	Method
determine the pathological stability	one day	determine the pathological stability with biopsy results confirmed during surgery

Trial Locations

Locations (1)

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