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Neoadjuvant chemotherapy for advanced breast cancer has led to an increased rate of breast-conserving surgery (BCS) in these patients. As the demand for preoperative localization methods grows among surgeons performing BCS, traditional localization techniques have shown limitations. For non-palpable breast lesions, preoperative localization has commonly been achieved using ultrasound-guided skin markings or needle localization. However, these methods present challenges, including difficulty in depth localization for patients with large breasts and limitations in real-time re-verification during surgery due to air artifacts after incision. Needle localization, although commonly used, is invasive and poses risks such as displacement or detachment of the needle.
Indocyanine green (ICG), a fluorescent dye that appears green to the naked eye and is detectable by near-infrared (NIR) cameras, has been widely and safely used in clinical practice via intravenous or subcutaneous administration. Recently, ICG combined with NIR imaging has been adopted for sentinel lymph node biopsy in breast cancer and melanoma surgeries and is increasingly used as a localization method for various tumors, replacing conventional techniques.
A preliminary study (IRB No. NCC2016-0071) conducted at the institution evaluated ICG injection and NIR fluorescence imaging for tumor localization in early breast cancer patients undergoing BCS. The study demonstrated the efficacy of ICG-based localization in reducing the rate of positive surgical margins.
The objective of this study is to evaluate the effectiveness of ICG-guided tumor localization with NIR fluorescence imaging in patients with advanced breast cancer treated with neoadjuvant chemotherapy. It is hypothesized that this technique will allow for more accurate tumor excision compared to conventional methods, ultimately improving surgical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICG-F | Experimental | Localization of breast cancer using indocyanine green fluorescence (ICG-F) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The margin-positive rate using the localization technique | Procedure | Localization of breast cancer using indocyanine green fluorescence (ICG-F) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Margin-positive rate in final pathological report | Collection of data for margin-positive rate from final pathological report after surgery | 10~35 days after surgery (the date when the pathological reports are available) |
| Measure | Description | Time Frame |
|---|---|---|
| Localization rate | Collection of data for tumor detection rate using ICG-F | The day of surgery |
| Centralization | Collection of data for the lengths from tumor to each resection margins |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seeyoun Lee, MD | Contact | +82-31-920-1736 | 1736 | seeyoun@ncc.re.kr |
| Name | Affiliation | Role |
|---|---|---|
| Seeyoun Lee, MD | National Cancer Center, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Recruiting | Goyang-si | Gyeonggi-do | 410-769 | South Korea |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 10~35 days after surgery (the date when the pathological reports are available) |
| Margin-positive rate in frozen section | Collection of data for margin-positive rate in frozen section during surgery | The day of surgery |
| Additional resection rate | Collection of data for additional resection rate according to results of frozen section during surgery | The day of surgery |
| Re-excision rate | Collection of data for re-excision rate (2nd operation) according to final pathological results | 10~35 days after surgery (the date when the pathological reports are available) |
| Adverse event rate | Collection of data for pigmentation rate of the injection site | 10~35 days after surgery (the date of follow-up after surgery) |
| D017437 |
| Skin and Connective Tissue Diseases |