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

NCT06780735 | Recruiting DMC

• 1 other identifier: NCC-2310621-1
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Breast Cancer

Keywords

Indocyanine green; Breast conserving surgery; Breast cancer; neoadjuvant chemotherapy; Tumor Localization; Near-Infrared Fluorescence Imaging

Outcome Measures

Primary Outcomes (1)

• Margin-positive rate in final pathological report

  Collection of data for margin-positive rate from final pathological report after surgery

  10~35 days after surgery (the date when the pathological reports are available)

Secondary Outcomes (6)

• Localization rate

  The day of surgery

• Centralization

  10~35 days after surgery (the date when the pathological reports are available)

• Margin-positive rate in frozen section

  The day of surgery

• Additional resection rate

  The day of surgery

• Re-excision rate

  10~35 days after surgery (the date when the pathological reports are available)

Study Arms (1)

ICG-F

EXPERIMENTAL

Localization of breast cancer using indocyanine green fluorescence (ICG-F)

Procedure: The margin-positive rate using the localization technique

Interventions

The margin-positive rate using the localization technique PROCEDURE

Localization of breast cancer using indocyanine green fluorescence (ICG-F)

ICG-F

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Seeyoun Lee, MD

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seeyoun Lee, MD

CONTACT

+82-31-920-1736; seeyoun@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, M.D., head of center for breast cancer

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: July 6, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

KR (1)