Benign Breast Neoplasm
Conditions
Keywords
Near-infrared fluorescence, Indocyanine green, ICG, Radio-guided surgery, breast cancer
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.
Interventions
None listed
Sponsors
National Cancer Center, Korea
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| non-palpable lesion localization rate | up to 6month | non-palpable lesion localization rate = number of patients complete excision of lesion / 20 enrolled patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lesion of resection size, completeness of resection | up to 6month | actual lesion of width\*height\*length / resection lesion of width\*height\*length |
Other
| Measure | Time frame | Description |
|---|---|---|
| physical assess | following up a week to 6 month | 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 |
Countries
South Korea
Outcome results
None listed