MedDataX Logo

Using LUminoMark vs Coventional Practice for Targeted Axillary Surgery

NCT ID: NCT06903429

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study was to compare the use of LuminoMarkTM as a method of targeting axillary lymph nodes with other existing methods used in each institution, such as charcoal staining, needle targeting, and ultrasound-guided skin marking, in patients with breast cancer clinically suspected of metastasis, with or without clipping at the time of diagnosis, regardless of the presence or absence of neoadjuvant chemotherapy. By doing so, the investigators aimed to confirm the safety and usefulness of LuminoMarkTM as a targeting method.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In breast cancer patients, lymph node targeting plays an important role in determining the stage and setting the treatment policy, and the existing methods for this purpose include charcoal staining, needle targeting, and ultrasound-guided skin marking. However, these methods have limitations in terms of detection rate and accuracy, and a new targeting method, LuminoMarkTM, shows the potential to replace them. The purpose of this study is to evaluate the detection rate and safety of lymph node targeting using LuminoMarkTM in breast cancer patients and to verify its effectiveness by comparing it with existing targeting methods. The study was designed as a prospective comparative study, and patients diagnosed with breast cancer and requiring lymph node targeting were divided into the LuminoMarkTM group and the existing method group. The existing method group selects a standard method among charcoal staining, needle targeting, and ultrasound-guided skin marking to perform targeting, and the lymph node detection rate, procedure time, complication rate, and patient satisfaction are the main evaluation indicators in both groups. After targeting, the suitability of the detected lymph nodes is confirmed through pathological analysis, and appropriate statistical analysis is performed to compare the difference in detection rates of each method. Through this study, the investigators evaluate whether LuminoMarkTM provides superior detection rates and safety compared to existing lymph node targeting methods, and based on this, the investigators aim to suggest a more effective and reliable targeting method for breast cancer patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Axillary Lymph Nodes Target Lesion

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Targeting Axillary lymph node breast cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LuminoMarkTM group

LuminoMarkTM using group for targeting of axillary lymph node

Group Type EXPERIMENTAL

Targeting of axillary lymph nodes using LuminoMark

Intervention Type PROCEDURE

This group used LuminoMark as a targeting method for axillary lymph nodes in breast cancer patients with suspected metastasis, comparing it to existing methods (charcoal staining, needle targeting, ultrasound-guided skin marking) to assess its safety and effectiveness, with procedural differences based on neoadjuvant chemotherapy status.

Conventional group

Conventional method using group for targeting of axillary lymph node

Group Type ACTIVE_COMPARATOR

Targeting of axillary lymph nodes using conventional method

Intervention Type PROCEDURE

This group used conventional method (charcoal staining, needle targeting, ultrasound-guided skin marking) as a targeting method for axillary lymph nodes in breast cancer patients with suspected metastasis, with procedural differences based on neoadjuvant chemotherapy status.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Targeting of axillary lymph nodes using LuminoMark

This group used LuminoMark as a targeting method for axillary lymph nodes in breast cancer patients with suspected metastasis, comparing it to existing methods (charcoal staining, needle targeting, ultrasound-guided skin marking) to assess its safety and effectiveness, with procedural differences based on neoadjuvant chemotherapy status.

Intervention Type PROCEDURE

Targeting of axillary lymph nodes using conventional method

This group used conventional method (charcoal staining, needle targeting, ultrasound-guided skin marking) as a targeting method for axillary lymph nodes in breast cancer patients with suspected metastasis, with procedural differences based on neoadjuvant chemotherapy status.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients aged 20 to 70 years
* Women diagnosed with primary invasive breast cancer through biopsy
* Patients with clinically and imaging-suspected axillary lymph node metastasis, confirmed pathologically (aspiration cytology or needle biopsy)
* Clinically staged T1-T4, N1-3
* Patients who have fully understood the clinical trial content (if possible) and signed the informed consent form

Exclusion Criteria

* Patients with inadequate radiological evaluation of the axilla before surgery
* Recurrent breast cancer or inflammatory breast cancer
* Breast cancer with distant metastasis (Stage 4)
* Patients with a history of hypersensitivity to the components of the investigational drug
* Patients scheduled for axillary dissection that does not require targeting of the target lesion
* Patients with active connective tissue disease (e.g., scleroderma, lupus) that has invaded the skin
* Patients with locally advanced breast cancer or inflammatory locally advanced breast cancer that is not amenable to surgery
* Patients with a history of hypersensitivity to the main component or excipients of the investigational drug
* Female subjects who may become pregnant during the clinical trial period and do not agree to use a highly effective non-hormonal contraception method (e.g., sterilization, intrauterine device, complete abstinence, vasectomy partner) from the time of investigational drug injection until the follow-up visit
* Pregnant or lactating women
* Patients who have participated in another clinical trial within 12 weeks before enrollment in this clinical trial
* Patients deemed unsuitable for participation by the investigator for any other reason
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kyungpook National University Chilgok Hospital

OTHER

Sponsor Role lead

Samsung Medical Center

OTHER

Sponsor Role collaborator

Gangnam Severance Hospital

OTHER

Sponsor Role collaborator

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

OTHER

Sponsor Role collaborator

Myongji Hospital

OTHER

Sponsor Role collaborator

Soonchunhyang University Hospital

OTHER

Sponsor Role collaborator

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

JeeYeon Lee

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Korean Breast Cancer Society Study Group

Role: STUDY_DIRECTOR

Korean Breast Cancer Society Study Group

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jeeyeon Lee, Associate professor in Kyungpook National University, MD, PhD

Role: CONTACT

Phone: 82-53-200-2707

Email: [email protected]

Joon Suk Moon, Clinical assistant professor, MD

Role: CONTACT

Phone: 82-53-200-7281

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

Takemoto N, Koyanagi A, Yasuda M, Yamamoto H. Comparison of the indocyanine green dye method versus the combined method of indigo carmine blue dye with indocyanine green fluorescence imaging for sentinel lymph node biopsy in breast conservative therapy for stage </=IIA breast cancer. BMC Womens Health. 2018 Sep 18;18(1):151. doi: 10.1186/s12905-018-0646-5.

Reference Type BACKGROUND
PMID: 30227837 (View on PubMed)

Lee J, Kang B, Jung JH, Kim HJ, Kim WH, Yang JD, Lee JS, Chae YS, Lee SJ, Lee IH, Park JY, Park NJ, Park HY. Feasibility of an indocyanine green-hyaluronic acid mixture (LuminoMark) for targeting suspicious axillary lymph nodes in patients with breast cancer. BMC Cancer. 2024 Dec 30;24(1):1588. doi: 10.1186/s12885-024-13175-9.

Reference Type BACKGROUND
PMID: 39736609 (View on PubMed)

Bang YJ, Choi HJ, Kim I, Lee MH, Lee S, Shin HJ, Nam SJ, Lee JE, Chae BJ, Lee SK, Ryu JM, Kim SW. The efficacy and safety of an indocyanine green-hyaluronic acid mixture (LuminoMark) for localization in patients with non-palpable breast lesions: A multicenter, randomized, open-label, parallel phase 3 clinical trial. Front Oncol. 2023 Mar 24;13:1039670. doi: 10.3389/fonc.2023.1039670. eCollection 2023.

Reference Type BACKGROUND
PMID: 37035212 (View on PubMed)

Kitzman JV, Martin JF, Holley JH, Huber WG. Determination of antipyrine in catfish plasma by high-performance liquid chromatography. J Chromatogr. 1988 Mar 11;437(1):306-10. doi: 10.1016/s0021-9673(00)90399-6. No abstract available.

Reference Type BACKGROUND
PMID: 3372671 (View on PubMed)

Lin J, Lin LS, Chen DR, Lin KJ, Wang YF, Chang YJ. Indocyanine green fluorescence method for sentinel lymph node biopsy in breast cancer. Asian J Surg. 2020 Dec;43(12):1149-1153. doi: 10.1016/j.asjsur.2020.02.003. Epub 2020 Mar 3.

Reference Type BACKGROUND
PMID: 32143963 (View on PubMed)

White KP, Sinagra D, Dip F, Rosenthal RJ, Mueller EA, Lo Menzo E, Rancati A. Indocyanine green fluorescence versus blue dye, technetium-99M, and the dual-marker combination of technetium-99M + blue dye for sentinel lymph node detection in early breast cancer-meta-analysis including consistency analysis. Surgery. 2024 Apr;175(4):963-973. doi: 10.1016/j.surg.2023.10.021. Epub 2023 Dec 13.

Reference Type BACKGROUND
PMID: 38097484 (View on PubMed)

Bargon CA, Huibers A, Young-Afat DA, Jansen BAM, Borel-Rinkes IHM, Lavalaye J, van Slooten HJ, Verkooijen HM, van Swol CFP, Doeksen A. Sentinel Lymph Node Mapping in Breast Cancer Patients Through Fluorescent Imaging Using Indocyanine Green: The INFLUENCE Trial. Ann Surg. 2022 Nov 1;276(5):913-920. doi: 10.1097/SLA.0000000000005633. Epub 2022 Jul 27.

Reference Type BACKGROUND
PMID: 35894448 (View on PubMed)

Kim WH, Kim HJ, Jung JH, Park HY, Lee J, Kim WW, Park JY, Chae YS, Lee SJ. Ultrasound-Guided Restaging and Localization of Axillary Lymph Nodes After Neoadjuvant Chemotherapy for Guidance of Axillary Surgery in Breast Cancer Patients: Experience with Activated Charcoal. Ann Surg Oncol. 2018 Feb;25(2):494-500. doi: 10.1245/s10434-017-6250-3. Epub 2017 Nov 13.

Reference Type BACKGROUND
PMID: 29134374 (View on PubMed)

Kim WH, Kim HJ, Jung JH, Park HY, Lee J, Kim WW, Park JY, Cheon H, Lee SM, Cho SH, Shin KM, Kim GC. Ultrasound-Guided Fine-Needle Aspiration of Non-palpable and Suspicious Axillary Lymph Nodes with Subsequent Removal after Tattooing: False-Negative Results and Concordance with Sentinel Lymph Nodes. Ultrasound Med Biol. 2017 Nov;43(11):2576-2581. doi: 10.1016/j.ultrasmedbio.2017.07.011. Epub 2017 Aug 19.

Reference Type BACKGROUND
PMID: 28830644 (View on PubMed)

Lee J, Jung JH, Kim WW, Lee RK, Kim HJ, Kim WH, Park JY, Jeong JY, Chae YS, Lee SJ, Park SH, Kim MY, Yang JD, Lee JW, Lee JS, Park HY. 5-year oncological outcomes of targeted axillary sampling in pT1-2N1 breast cancer. Asian J Surg. 2019 Jun;42(6):681-687. doi: 10.1016/j.asjsur.2018.10.004. Epub 2018 Nov 22.

Reference Type BACKGROUND
PMID: 30470459 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KBCSG 36

Identifier Type: -

Identifier Source: org_study_id