Status:
NOT_YET_RECRUITING
Using LUminoMark vs Coventional Practice for Targeted Axillary Surgery
Lead Sponsor:
Kyungpook National University Chilgok Hospital
Collaborating Sponsors:
Samsung Medical Center
Gangnam Severance Hospital
Conditions:
Breast Cancer
Axillary Lymph Nodes
Eligibility:
All Genders
20-70 years
Phase:
NA
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 t...
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT06903429
Start Date
May 1 2025
End Date
December 31 2027
Last Update
March 30 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.