Using LUminoMark vs Coventional Practice for Targeted Axillary Surgery

NCT06903429 | Not Yet Recruiting DMC

• 1 other identifier: KBCSG 36
• Study Type: interventional
• Target: 330
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Cancer; Axillary Lymph Nodes; Target Lesion

Keywords

Targeting; Axillary lymph node; breast cancer

Outcome Measures

Primary Outcomes (2)

• Accuracy of the axillary lymph node targeting method

  The outcome will be assessed by determining whether the preoperatively marked (targeted) lymph node is successfully identified and retrieved during surgery, and confirmed by postoperative pathological examination. Success (match): The retrieved lymph node is matched with targeted lymph node. Failure (not match): The retrieved lymph node is not matched with targeted lymph node.

  From enrollment to the end of observation at 3 weeks

• Comparison the accuracy rate between LuminoMark group and conventional group

  Compare the rate at which the lymph nodes are accurately detected using charcoal staining, needle targeting, ultrasound-guided marking, etc., with the rate at which they are detected using LuminoMark.

  At the end of the trial (up to 1 year)

Secondary Outcomes (4)

• Comparion of surgical time between two group

  During surgery

• Comparison of complications between two groups

  From enrollment to the end of observation at 3 weeks

• Adverse drug reactions

  From enrollment to the end of observation at 3 weeks

• Concordance rate between sentinel lymph node and targeted lymph node in both group

  From enrollment to the end of observation at 3 weeks

Study Arms (2)

LuminoMarkTM group

EXPERIMENTAL

LuminoMarkTM using group for targeting of axillary lymph node

Procedure: Targeting of axillary lymph nodes using LuminoMark

Conventional group

ACTIVE COMPARATOR

Conventional method using group for targeting of axillary lymph node

Procedure: Targeting of axillary lymph nodes using conventional method

Interventions

Targeting of axillary lymph nodes using LuminoMark 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.

LuminoMarkTM group

Targeting of axillary lymph nodes using conventional method 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.

Conventional group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyungpook National University Chilgok Hospital: lead
• Samsung Medical Center: collaborator
• Gangnam Severance Hospital: collaborator
• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: collaborator
• Myongji Hospital: collaborator
• Soonchunhyang University Hospital: collaborator

Related Publications (10)

• 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.

  PMID: 30227837 BACKGROUND

• 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.

  PMID: 39736609 BACKGROUND

• 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.

  PMID: 37035212 BACKGROUND

• 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.

  PMID: 3372671 BACKGROUND

• 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.

  PMID: 32143963 BACKGROUND

• 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.

  PMID: 38097484 BACKGROUND

• 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.

  PMID: 35894448 BACKGROUND

• 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.

  PMID: 29134374 BACKGROUND

• 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.

  PMID: 28830644 BACKGROUND

• 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.

  PMID: 30470459 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Erythema Multiforme

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Erythema; Skin Diseases, Vesiculobullous

Study Officials

• Korean Breast Cancer Society Study Group

  Korean Breast Cancer Society Study Group

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

82-53-200-2707; j.lee@knu.ac.kr

Joon Suk Moon, Clinical assistant professor, MD

CONTACT

82-53-200-7281; joonsukm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 30, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share