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

NCT ID: NCT02172989

Last Updated: 2015-06-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-05-31

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.

Conditions

Benign Breast Neoplasm

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

So-Youn Jung

Medical Dotor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

So-Youn Jung

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

NCC-1410202-1

Identifier Type: -

Identifier Source: org_study_id