Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Benign Breast Neoplasm ; Observational Pilot Study for 20 Patients.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Benign Breast Neoplasm
- Sponsor
- National Cancer Center, Korea
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- non-palpable lesion localization rate
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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:
- As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
- 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.
Investigators
So-Youn Jung
Medical Dotor
National Cancer Center, Korea
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
Outcomes
Primary Outcomes
non-palpable lesion localization rate
Time Frame: up to 6month
non-palpable lesion localization rate = number of patients complete excision of lesion / 20 enrolled patients
Secondary Outcomes
- lesion of resection size, completeness of resection(up to 6month)