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Surgical Outcome of BCS Using ICG-F in Breast Cancer Patients After Preoperative Chemotherapy

RecruitingNAAges 18 Years - anyFemaleNational Cancer Center, Korea
NCT06780735 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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,

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📋 Eligibility rules (as published)
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
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What it tests

  • The margin-positive rate using the localization technique
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Where

1 site
National Cancer Center
Goyang-si, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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