Breast NeoplasmsNCT06780735
Surgical Outcome of BCS Using ICG-F in Breast Cancer Patients After Preoperative Chemotherapy
A study testing The margin-positive rate using the localization technique in people with Breast Neoplasms and Breast Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms, Breast Cancer
- What is being tested?
- The margin-positive rate using the localization technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Jul 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
Seeyoun Lee, +82-31-920-1736 ext. 1736, seeyoun@ncc.re.kr
Kwideuk Son, +82-31-920-0848 ext. 0848, 75095@ncc.re.kr
About this study
Official title: 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.
Read more
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
- Being tested
- The margin-positive rate using the localization technique
- Keywords
- Indocyanine green, Breast conserving surgery, Breast cancer, neoadjuvant chemotherapy, Tumor Localization, Near-Infrared Fluorescence Imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The margin-positive rate using the localization techniqueProcedure or surgery
Localization of breast cancer using indocyanine green fluorescence (ICG-F)
| Study group | Role | What they receive |
|---|---|---|
| ICG-F | Experimental | Localization of breast cancer using indocyanine green fluorescence (ICG-F) Receives: Procedure: The margin-positive rate using the localization technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Margin-positive rate in final pathological report
Collection of data for margin-positive rate from final pathological report after surgery
Measured: 10~35 days after surgery (the date when the pathological reports are available)
Secondary outcomes (6)
Localization rate
Collection of data for tumor detection rate using ICG-F
Measured: The day of surgery
Centralization
Collection of data for the lengths from tumor to each resection margins
Measured: 10~35 days after surgery (the date when the pathological reports are available)
Margin-positive rate in frozen section
Collection of data for margin-positive rate in frozen section during surgery
Measured: The day of surgery
Additional resection rate
Collection of data for additional resection rate according to results of frozen section during surgery
Measured: The day of surgery
Re-excision rate
Collection of data for re-excision rate (2nd operation) according to final pathological results
Measured: 10~35 days after surgery (the date when the pathological reports are available)
Adverse event rate
Collection of data for pigmentation rate of the injection site
Measured: 10~35 days after surgery (the date of follow-up after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start6 Jul 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Seeyoun Lee, National Cancer Center, Korea
- Investigators
- Seeyoun Lee, MD, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780735
- Sponsor's protocol ID
- NCC-2310621-1
- Status last verified
- Mar 2025
- First submitted
- 13 Jan 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Outcome of Breast Conserving Surgery Using Indocyanine Green Fluorescence in Breast Cancer Patients After Preoperative Chemotherapy: a Prospective Study
- ClinicalTrials.gov ID
- NCT06780735
- Acronym / sponsor ID
- NCC-2310621-1
- Conditions
- Breast Neoplasms, Breast Cancer
- Keywords
- Indocyanine green, Breast conserving surgery, Breast cancer, neoadjuvant chemotherapy, Tumor Localization, Near-Infrared Fluorescence Imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG-F | Experimental | Procedure: The margin-positive rate using the localization techniqueLocalization of breast cancer using indocyanine green fluorescence (ICG-F) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The margin-positive rate using the localization techniqueLocalization of breast cancer using indocyanine green fluorescence (ICG-F) | Procedure or surgery | ICG-F |
Primary outcome
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
6 secondary outcomes
Localization rate
Time frame: The day of surgery
Centralization
Time frame: 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
Additional resection rate
Time frame: The day of surgery
Re-excision rate
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seeyoun Lee, MD principal investigator
National Cancer Center, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The margin-positive rate using the localization technique in people with Breast Neoplasms and Breast Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seeyoun Lee, MD (+82-31-920-1736 ext. 1736, seeyoun@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Margin-positive rate in final pathological report (time frame: 10~35 days after surgery (the date when the pathological reports are available)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.