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NCT Number: NCT06780735

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The margin-positive rate using the localization technique

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Localization rate

    Time frame: The day of surgery

    Collection of data for tumor detection rate using ICG-F

  2. 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

  3. Margin-positive rate in frozen section

    Time frame: The day of surgery

    Collection of data for margin-positive rate in frozen section during surgery

  4. Additional resection rate

    Time frame: The day of surgery

    Collection of data for additional resection rate according to results of frozen section during surgery

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Seeyoun Lee, MD

CONTACT

[email protected]

+82-31-920-1736 ext. 1736

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2025
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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