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

March 10, 2025 updated by: Seeyoun Lee, National Cancer Center, Korea

Surgical Outcome of Breast Conserving Surgery Using Indocyanine Green Fluorescence in Breast Cancer Patients After Preoperative Chemotherapy: a Prospective Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • Recruiting
        • National Cancer Center
        • Contact:
        • Contact:
        • Contact:
          • SEEYOUN LEE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICG-F
Localization of breast cancer using indocyanine green fluorescence (ICG-F)
Procedure: The margin-positive rate using the localization technique
Localization of breast cancer using indocyanine green fluorescence (ICG-F)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Margin-positive rate in final pathological report
Time Frame: 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
10~35 days after surgery (the date when the pathological reports are available)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Localization rate
Time Frame: The day of surgery
Collection of data for tumor detection rate using ICG-F
The day of surgery
Centralization
Time Frame: 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
10~35 days after surgery (the date when the pathological reports are available)
Margin-positive rate in frozen section
Time Frame: The day of surgery
Collection of data for margin-positive rate in frozen section during surgery
The day of surgery
Additional resection rate
Time Frame: The day of surgery
Collection of data for additional resection rate according to results of frozen section during surgery
The day of surgery
Re-excision rate
Time Frame: 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
10~35 days after surgery (the date when the pathological reports are available)
Adverse event rate
Time Frame: 10~35 days after surgery (the date of follow-up after surgery)
Collection of data for pigmentation rate of the injection site
10~35 days after surgery (the date of follow-up after surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Seeyoun Lee, MD, National Cancer Center, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC-2310621-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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