Clinical trial NCT06903429: Using LUminoMark vs Coventional Practice for Targeted Axillary Surgery
Official title: A Comparative Study to Evaluate Targeting Methods for Axillary Surgery in Patients With Clinically Node-positive Breast Cancer: A Prospective Multicenter Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Axillary Lymph Nodes
Target Lesion
Keywords: Targeting
Axillary lymph node
breast cancer
Lead sponsor: Kyungpook National University Chilgok Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
name: Gangnam Severance Hospital
name: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Myongji Hospital
name: Soonchunhyang University Hospital
First posted: 2025-03-30
Enrollment: 330
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of the axillary lymph node targeting method
timeFrame: From enrollment to the end of observation at 3 weeks
measure: Comparison the accuracy rate between LuminoMark group and conventional group
timeFrame: At the end of the trial (up to 1 year)
Secondary outcomes:
measure: Comparion of surgical time between two group
timeFrame: During surgery
measure: Comparison of complications between two groups
timeFrame: From enrollment to the end of observation at 3 weeks
measure: Adverse drug reactions
timeFrame: From enrollment to the end of observation at 3 weeks
measure: Concordance rate between sentinel lymph node and targeted lymph node in both group
timeFrame: From enrollment to the end of observation at 3 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Korean Breast Cancer Society Study Group
name: Korean Breast Cancer Society Study Group
role: STUDY_DIRECTOR
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