Clinical trial · Interventional
Using LUminoMark vs Coventional Practice for Targeted Axillary Surgery
A Comparative Study to Evaluate Targeting Methods for Axillary Surgery in Patients With Clinically Node-positive Breast Cancer: A Prospective Multicenter Pilot Study
NCT06903429CI-TRIAL-00087871LUCASnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Axillary Lymph Nodes | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Target Lesion | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Targeting of axillary lymph nodes using conventional method | Procedure | — | UNRESOLVED |
| Targeting of axillary lymph nodes using LuminoMark | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LuminoMarkTM group
- description
- LuminoMarkTM using group for targeting of axillary lymph node
- interventionNames
- Procedure: Targeting of axillary lymph nodes using LuminoMark
- type
- ACTIVE_COMPARATOR
- label
- Conventional group
- description
- Conventional method using group for targeting of axillary lymph node
- interventionNames
- Procedure: Targeting of axillary lymph nodes using conventional method
Primary outcomes (2)
- measure
- Accuracy of the axillary lymph node targeting method
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDTakemoto 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
- BACKGROUNDLee 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
- BACKGROUNDBang 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
- BACKGROUNDKitzman 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
- BACKGROUNDLin 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
- BACKGROUNDWhite 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.