Using LUminoMark vs Coventional Practice for Targeted Axillary Surgery

Launched by KYUNGPOOK NATIONAL UNIVERSITY CHILGOK HOSPITAL · Mar 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new method called LuminoMarkTM to see how well it works in targeting lymph nodes in the armpit area for patients with breast cancer. The goal is to compare LuminoMarkTM with other methods currently used, like charcoal staining and ultrasound marking. Researchers want to find out if LuminoMarkTM is safe and effective for patients who have suspected spread of cancer to these lymph nodes.

To participate in this trial, patients should be between the ages of 20 and 70 and have been diagnosed with invasive breast cancer. They must also have signs that the cancer may have spread to their lymph nodes confirmed by tests like a needle biopsy. However, there are some criteria that would exclude patients from the trial, such as having a different stage of cancer or certain medical conditions. If eligible, participants can expect to undergo procedures using LuminoMarkTM and will be closely monitored for safety and effectiveness. The trial is currently not recruiting participants yet, so more information will be available soon.

Gender

ALL

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