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

Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Benign Breast Neoplasm ; Observational Pilot Study for 20 Patients.

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.

Study Overview

• Status: Completed
• Conditions: Benign Breast Neoplasm

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
      • National Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

nonpalpable benign breast lesion ≤ 2cm in patients with breast cancer.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
non-palpable lesion localization rate	non-palpable lesion localization rate = number of patients complete excision of lesion / 20 enrolled patients	up to 6month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lesion of resection size, completeness of resection	actual lesion of width*height*length / resection lesion of width*height*length	up to 6month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
physical assess	number of patients with pigmented skin lesion, number of patients with complication, number of patients with breast lymphedema, number of patients with residual breast lesion using breast ultrsound	following up a week to 6 month

Collaborators and Investigators

• Sponsor: National Cancer Center, Korea

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: June 23, 2014
• First Submitted That Met QC Criteria: June 23, 2014
• First Posted (Estimate): June 24, 2014

Study Record Updates

• Last Update Posted (Estimate): June 19, 2015
• Last Update Submitted That Met QC Criteria: June 17, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: breast cancer; Near-infrared fluorescence; Indocyanine green, ICG; Radio-guided surgery
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Site; Breast Diseases; Neoplasms; Breast Neoplasms
• Other Study ID Numbers: NCC-1410202-1