Using LUminoMark vs Coventional Practice for Targeted Axillary Surgery (LUCAS)

March 24, 2025 updated by: JeeYeon Lee, Kyungpook National University Chilgok Hospital

A Comparative Study to Evaluate Targeting Methods for Axillary Surgery in Patients With Clinically Node-positive Breast Cancer: A Prospective Multicenter Pilot Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jeeyeon Lee, Associate professor in Kyungpook National University, MD, PhD
  • Phone Number: 82-53-200-2707
  • Email: j.lee@knu.ac.kr

Study Contact Backup

  • Name: Joon Suk Moon, Clinical assistant professor, MD
  • Phone Number: 82-53-200-7281
  • Email: joonsukm@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LuminoMarkTM group
LuminoMarkTM using group for targeting of axillary lymph node
Procedure: Targeting of axillary lymph nodes using LuminoMark
This group used LuminoMark as a targeting method for axillary lymph nodes in breast cancer patients with suspected metastasis, comparing it to existing methods (charcoal staining, needle targeting, ultrasound-guided skin marking) to assess its safety and effectiveness, with procedural differences based on neoadjuvant chemotherapy status.
Active Comparator: Conventional group
Conventional method using group for targeting of axillary lymph node
Procedure: Targeting of axillary lymph nodes using conventional method
This group used conventional method (charcoal staining, needle targeting, ultrasound-guided skin marking) as a targeting method for axillary lymph nodes in breast cancer patients with suspected metastasis, with procedural differences based on neoadjuvant chemotherapy status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of the axillary lymph node targeting method
Time Frame: From enrollment to the end of observation at 3 weeks

The outcome will be assessed by determining whether the preoperatively marked (targeted) lymph node is successfully identified and retrieved during surgery, and confirmed by postoperative pathological examination.

Success (match): The retrieved lymph node is matched with targeted lymph node.

Failure (not match): The retrieved lymph node is not matched with targeted lymph node.
From enrollment to the end of observation at 3 weeks
Comparison the accuracy rate between LuminoMark group and conventional group
Time Frame: At the end of the trial (up to 1 year)
Compare the rate at which the lymph nodes are accurately detected using charcoal staining, needle targeting, ultrasound-guided marking, etc., with the rate at which they are detected using LuminoMark.
At the end of the trial (up to 1 year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparion of surgical time between two group
Time Frame: During surgery
Comparison of time from skin incision to detection of marked axillary lymph nodes Comparison of total axillary surgical time
During surgery
Comparison of complications between two groups
Time Frame: From enrollment to the end of observation at 3 weeks
Compare the postoperative complications after surgery
From enrollment to the end of observation at 3 weeks
Adverse drug reactions
Time Frame: From enrollment to the end of observation at 3 weeks
Compare the incidence of adverse drug reactions between two groups
From enrollment to the end of observation at 3 weeks
Concordance rate between sentinel lymph node and targeted lymph node in both group
Time Frame: From enrollment to the end of observation at 3 weeks
Concordance rate between sentinel lymph node and targeted lymph node in both group
From enrollment to the end of observation at 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Chilgok Hospital

Collaborators

Samsung Medical Center
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Gangnam Severance Hospital
Soonchunhyang University Hospital
Myongji Hospital

Investigators

  • Study Director: Korean Breast Cancer Society Study Group, Korean Breast Cancer Society Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 24, 2025

First Posted (Actual)

March 30, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KBCSG 36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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