Using LUminoMark vs Coventional Practice for Targeted Axillary Surgery (NCT06903429) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Using LUminoMark vs Coventional Practice for Targeted Axillary Surgery
330 participantsStarted 2025-05-01
Plain-language 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.
Who can participate
Age range
20 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 w…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Accuracy of the axillary lymph node targeting method
Timeframe: From enrollment to the end of observation at 3 weeks
2
Comparison the accuracy rate between LuminoMark group and conventional group
Timeframe: At the end of the trial (up to 1 year)
Trial details
NCT IDNCT06903429
SponsorKyungpook National University Chilgok Hospital
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2026-12-31
Contact for this trial
Jeeyeon Lee, Associate professor in Kyungpook National University, MD, PhD