Breast Cancer
Conditions
Keywords
Near-infrared fluorescence, Indocyanine green, ICG, 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
DRUGindocyanine green
As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
Sponsors
National Cancer Center, Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* nonpalpable breast tumor \< 5cm in patients with breast cancer. * consented patients with more than 18 years * Eastern Cooperative Oncology Group Performance status 0 or 1 * patients who need breast biopsy as treatment for breast cancer.
Exclusion criteria
* nonpalpable breast tumor ≥ 5cm in patients with breast cancer. * inflammatory cancer of breast or patients who need MRM * pregnancy * history of severe allergy to ICG(Indocyanine Green) * iode hypersensitiveness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| detection rate | one day | after complete resection with intraoperative ultrasound confirmed the lesion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| determine the pathological stability | one day | determine the pathological stability with biopsy results confirmed during surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| Side effects and availability Side effects and availability Side effects and availability side effects and availability | following up a week to 3 month | Itchiness, erythema, rash and other allergic reactions there could have shots later. Itchiness, erythema, rash and other allergic reactions there could have shots later. Itchiness, erythema, rash and other allergic reactions there could have shots later. Itchiness, erythema, rash and other allergic reactions there could have shots later. |
| side effects and availability | following up a week to 3 month | After scanning, difficulty breathing, a decrease in blood pressure checked whether he had o reaction, such as anaphylactic shock. |
| side effects ans availability | following up a week to 3 month | The skin discoloration, verify that there aren't stay in a follow-up after three months after surgery. |
Countries
South Korea
Contacts
Primary ContactSo-Youn Jung
Outcome results
None listed