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

Last updated: March 10, 2025
Sponsor: National Cancer Center, Korea
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

The margin-positive rate using the localization technique

Clinical Study ID

NCT06780735
NCC-2310621-1
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • The Patient with locally advanced breast cancer who is eligible forbreast-conserving surgery after receiving neoadjuvant chemotherapy

  • Aged over 18 years old

  • ECOG performance status: 0 or 1

  • The patients with written informed consent

Exclusion

Exclusion Criteria:

  • The patient who requires total mastectomy after receiving neoadjuvant chemotherapy

  • The patient with no residual mass on ultrasonography or only withmicrocalcifications

  • 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

Total Participants: 128
Treatment Group(s): 1
Primary Treatment: The margin-positive rate using the localization technique
Phase:
Study Start date:
July 06, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • National Cancer Center

    Goyang-si, Gyeonggi-do 410-769
    Korea, Republic of

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.