Clinical trial NCT06780735: Surgical Outcome of BCS Using ICG-F in Breast Cancer Patients After Preoperative Chemotherapy
Official title: Surgical Outcome of Breast Conserving Surgery Using Indocyanine Green Fluorescence in Breast Cancer Patients After Preoperative Chemotherapy: a Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasms
Breast Cancer
Keywords: Indocyanine green
Breast conserving surgery
Breast cancer
neoadjuvant chemotherapy
Tumor Localization
Near-Infrared Fluorescence Imaging
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2025-01-17
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Margin-positive rate in final pathological report
timeFrame: 10~35 days after surgery (the date when the pathological reports are available)
Secondary outcomes:
measure: Localization rate
timeFrame: The day of surgery
measure: Centralization
timeFrame: 10~35 days after surgery (the date when the pathological reports are available)
measure: Margin-positive rate in frozen section
timeFrame: The day of surgery
measure: Additional resection rate
timeFrame: The day of surgery
measure: Re-excision rate
timeFrame: 10~35 days after surgery (the date when the pathological reports are available)
measure: Adverse event rate
timeFrame: 10~35 days after surgery (the date of follow-up after surgery)
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center, Korea
name: Seeyoun Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: