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

Not Applicable

Recruiting

• Conditions: Breast Neoplasms; Breast Cancer

• Registration Number: NCT06780735
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-06
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-13
• Study First Posted: 2025-01-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Margin-positive rate in final pathological report	10~35 days after surgery (the date when the pathological reports are available)	Collection of data for margin-positive rate from final pathological report after surgery

Secondary Outcome Measures

Name	Time	Method
Localization rate	The day of surgery	Collection of data for tumor detection rate using ICG-F
Centralization	10~35 days after surgery (the date when the pathological reports are available)	Collection of data for the lengths from tumor to each resection margins
Margin-positive rate in frozen section	The day of surgery	Collection of data for margin-positive rate in frozen section during surgery
Additional resection rate	The day of surgery	Collection of data for additional resection rate according to results of frozen section during surgery
Re-excision rate	10~35 days after surgery (the date when the pathological reports are available)	Collection of data for re-excision rate (2nd operation) according to final pathological results
Adverse event rate	10~35 days after surgery (the date of follow-up after surgery)	Collection of data for pigmentation rate of the injection site

Trial Locations

Locations (1)

National Cancer Center; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of