Surgical Outcome of BCS Using ICG-F in Breast Cancer Patients After Preoperative Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: The margin-positive rate using the localization technique.
- Who it may be relevant to
- Registry conditions: Breast Neoplasms, Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Surgical Outcome of Breast Conserving Surgery Using Indocyanine Green Fluorescence in Breast Cancer Patients After Preoperative Chemotherapy: a Prospective Study
Overview
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.
Interventions
- Procedure The margin-positive rate using the localization technique
Localization of breast cancer using indocyanine green fluorescence (ICG-F)
Primary outcome measures
- Margin-positive rate in final pathological report [Time frame: 10~35 days after surgery (the date when the pathological reports are available)]
Secondary outcome measures (6)
- Localization rate [Time frame: The day of surgery]
- Centralization [Time frame: 10~35 days after surgery (the date when the pathological reports are available)]
- Margin-positive rate in frozen section [Time frame: The day of surgery]
- Additional resection rate [Time frame: The day of surgery]
- Re-excision rate [Time frame: 10~35 days after surgery (the date when the pathological reports are available)]
- Adverse event rate [Time frame: 10~35 days after surgery (the date of follow-up after surgery)]
Eligibility criteria
Inclusion criteria
- The Patient with locally advanced breast cancer who is eligible for breast-conserving surgery after receiving neoadjuvant chemotherapy
- Aged over 18 years old
- ECOG performance status: 0 or 1
- The patients with written informed consent
Exclusion criteria
- The patient who requires total mastectomy after receiving neoadjuvant chemotherapy
- The patient with no residual mass on ultrasonography or only with microcalcifications
- Pregnant or lactating patient
- The patient with a disability to understand and provide consent
- The patient with severe allergic history to indocyanine green
- Iodine-sensitive patient
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- National Cancer Center — Goyang-si
Identifiers
NCT: NCT06780735 · NCC-2310621-1