Breast CancerLUCASNCT06903429
Using LUminoMark vs Coventional Practice for Targeted Axillary Surgery
A study testing Targeting of axillary lymph nodes using LuminoMark and Targeting of axillary lymph nodes using conventional method in people with Breast Cancer and Axillary Lymph Nodes, run by Kyungpook National University Chilgok Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Breast Cancer, Axillary Lymph Nodes, Target Lesion
- What is being tested?
- Targeting of axillary lymph nodes using LuminoMark and Targeting of axillary lymph nodes using conventional method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jeeyeon Lee, Associate professor in Kyungpook National University, MD, PhD contact
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer, Axillary Lymph Nodes, Target Lesion
- Being tested
- Targeting of axillary lymph nodes using LuminoMark, Targeting of axillary lymph nodes using conventional method
- Keywords
- Targeting, Axillary lymph node, breast cancer
- Medical subject headings
- Breast Neoplasms, Erythema Multiforme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeting of axillary lymph nodes using LuminoMarkProcedure or surgery
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.
Targeting of axillary lymph nodes using conventional methodProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| LuminoMarkTM group | Experimental | LuminoMarkTM using group for targeting of axillary lymph node Receives: Procedure: Targeting of axillary lymph nodes using LuminoMark |
| Conventional group | Active comparator | Conventional method using group for targeting of axillary lymph node Receives: Procedure: Targeting of axillary lymph nodes using conventional method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the axillary lymph node targeting method
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.
Measured: From enrollment to the end of observation at 3 weeks
Comparison the accuracy rate between LuminoMark group and conventional group
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.
Measured: At the end of the trial (up to 1 year)
Secondary outcomes (4)
Comparion of surgical time between two group
Comparison of time from skin incision to detection of marked axillary lymph nodes Comparison of total axillary surgical time
Measured: During surgery
Comparison of complications between two groups
Compare the postoperative complications after surgery
Measured: From enrollment to the end of observation at 3 weeks
Adverse drug reactions
Compare the incidence of adverse drug reactions between two groups
Measured: From enrollment to the end of observation at 3 weeks
Concordance rate between sentinel lymph node and targeted lymph node in both group
Concordance rate between sentinel lymph node and targeted lymph node in both group
Measured: From enrollment to the end of observation at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Chilgok Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center, Gangnam Severance Hospital, Chung-Ang University Hospital, Myongji Hospital, Soonchunhyang University Hospital
- Responsible party
- Principal investigator, JeeYeon Lee, Kyungpook National University Chilgok Hospital
- Investigators
- Korean Breast Cancer Society Study Group, Study director, Korean Breast Cancer Society Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903429
- Sponsor's protocol ID
- KBCSG 36
- Acronym
- LUCAS
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Takemoto N, Koyanagi A, Yasuda M, Yamamoto H. Comparison of the indocyanine green dye method versus the combined method of indigo carmine blue dye with indocyanine green fluorescence imaging for sentinel lymph node biopsy in breast conservative therapy for stage </=IIA breast cancer. BMC Womens Health. 2018 Sep 18;18(1):151. doi: 10.1186/s12905-018-0646-5.
PubMed 30227837Lee J, Kang B, Jung JH, Kim HJ, Kim WH, Yang JD, Lee JS, Chae YS, Lee SJ, Lee IH, Park JY, Park NJ, Park HY. Feasibility of an indocyanine green-hyaluronic acid mixture (LuminoMark) for targeting suspicious axillary lymph nodes in patients with breast cancer. BMC Cancer. 2024 Dec 30;24(1):1588. doi: 10.1186/s12885-024-13175-9.
PubMed 39736609Bang YJ, Choi HJ, Kim I, Lee MH, Lee S, Shin HJ, Nam SJ, Lee JE, Chae BJ, Lee SK, Ryu JM, Kim SW. The efficacy and safety of an indocyanine green-hyaluronic acid mixture (LuminoMark) for localization in patients with non-palpable breast lesions: A multicenter, randomized, open-label, parallel phase 3 clinical trial. Front Oncol. 2023 Mar 24;13:1039670. doi: 10.3389/fonc.2023.1039670. eCollection 2023.
PubMed 37035212Kitzman JV, Martin JF, Holley JH, Huber WG. Determination of antipyrine in catfish plasma by high-performance liquid chromatography. J Chromatogr. 1988 Mar 11;437(1):306-10. doi: 10.1016/s0021-9673(00)90399-6. No abstract available.
PubMed 3372671Lin J, Lin LS, Chen DR, Lin KJ, Wang YF, Chang YJ. Indocyanine green fluorescence method for sentinel lymph node biopsy in breast cancer. Asian J Surg. 2020 Dec;43(12):1149-1153. doi: 10.1016/j.asjsur.2020.02.003. Epub 2020 Mar 3.
PubMed 32143963White KP, Sinagra D, Dip F, Rosenthal RJ, Mueller EA, Lo Menzo E, Rancati A. Indocyanine green fluorescence versus blue dye, technetium-99M, and the dual-marker combination of technetium-99M + blue dye for sentinel lymph node detection in early breast cancer-meta-analysis including consistency analysis. Surgery. 2024 Apr;175(4):963-973. doi: 10.1016/j.surg.2023.10.021. Epub 2023 Dec 13.
PubMed 38097484Bargon CA, Huibers A, Young-Afat DA, Jansen BAM, Borel-Rinkes IHM, Lavalaye J, van Slooten HJ, Verkooijen HM, van Swol CFP, Doeksen A. Sentinel Lymph Node Mapping in Breast Cancer Patients Through Fluorescent Imaging Using Indocyanine Green: The INFLUENCE Trial. Ann Surg. 2022 Nov 1;276(5):913-920. doi: 10.1097/SLA.0000000000005633. Epub 2022 Jul 27.
PubMed 35894448Kim WH, Kim HJ, Jung JH, Park HY, Lee J, Kim WW, Park JY, Chae YS, Lee SJ. Ultrasound-Guided Restaging and Localization of Axillary Lymph Nodes After Neoadjuvant Chemotherapy for Guidance of Axillary Surgery in Breast Cancer Patients: Experience with Activated Charcoal. Ann Surg Oncol. 2018 Feb;25(2):494-500. doi: 10.1245/s10434-017-6250-3. Epub 2017 Nov 13.
PubMed 29134374Kim WH, Kim HJ, Jung JH, Park HY, Lee J, Kim WW, Park JY, Cheon H, Lee SM, Cho SH, Shin KM, Kim GC. Ultrasound-Guided Fine-Needle Aspiration of Non-palpable and Suspicious Axillary Lymph Nodes with Subsequent Removal after Tattooing: False-Negative Results and Concordance with Sentinel Lymph Nodes. Ultrasound Med Biol. 2017 Nov;43(11):2576-2581. doi: 10.1016/j.ultrasmedbio.2017.07.011. Epub 2017 Aug 19.
PubMed 28830644Lee J, Jung JH, Kim WW, Lee RK, Kim HJ, Kim WH, Park JY, Jeong JY, Chae YS, Lee SJ, Park SH, Kim MY, Yang JD, Lee JW, Lee JS, Park HY. 5-year oncological outcomes of targeted axillary sampling in pT1-2N1 breast cancer. Asian J Surg. 2019 Jun;42(6):681-687. doi: 10.1016/j.asjsur.2018.10.004. Epub 2018 Nov 22.
PubMed 30470459
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06903429
- Acronym / sponsor ID
- LUCAS / KBCSG 36
- Conditions
- Breast Cancer, Axillary Lymph Nodes, Target Lesion
- Keywords
- Targeting, Axillary lymph node, breast cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Kyungpook National University Chilgok HospitalUniversity, hospital or other
- Collaborators
- Samsung Medical Center, Gangnam Severance Hospital, Chung-Ang University Hospital, Myongji Hospital, Soonchunhyang University Hospital
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LuminoMarkTM group | Experimental | Procedure: Targeting of axillary lymph nodes using LuminoMarkLuminoMarkTM using group for targeting of axillary lymph node |
| Conventional group | Active comparator | Procedure: Targeting of axillary lymph nodes using conventional methodConventional method using group for targeting of axillary lymph node |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeting of axillary lymph nodes using LuminoMarkThis 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. | Procedure or surgery | LuminoMarkTM group |
| Targeting of axillary lymph nodes using conventional methodThis 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. | Procedure or surgery | Conventional group |
Primary outcome
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.
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.
4 secondary outcomes
Comparion of surgical time between two group
Time frame: During surgery
Comparison of complications between two groups
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Background: PubMed 30227837Takemoto N, Koyanagi A, Yasuda M, Yamamoto H. Comparison of the indocyanine green dye method versus the combined method of indigo carmine blue dye with indocyanine green fluorescence imaging for sentinel lymph node biopsy in breast conservative therapy for stage </=IIA breast cancer. BMC Womens Health. 2018 Sep 18;18(1):151. doi: 10.1186/s12905-018-0646-5.
- Background: PubMed 39736609Lee J, Kang B, Jung JH, Kim HJ, Kim WH, Yang JD, Lee JS, Chae YS, Lee SJ, Lee IH, Park JY, Park NJ, Park HY. Feasibility of an indocyanine green-hyaluronic acid mixture (LuminoMark) for targeting suspicious axillary lymph nodes in patients with breast cancer. BMC Cancer. 2024 Dec 30;24(1):1588. doi: 10.1186/s12885-024-13175-9.
- Background: PubMed 37035212Bang YJ, Choi HJ, Kim I, Lee MH, Lee S, Shin HJ, Nam SJ, Lee JE, Chae BJ, Lee SK, Ryu JM, Kim SW. The efficacy and safety of an indocyanine green-hyaluronic acid mixture (LuminoMark) for localization in patients with non-palpable breast lesions: A multicenter, randomized, open-label, parallel phase 3 clinical trial. Front Oncol. 2023 Mar 24;13:1039670. doi: 10.3389/fonc.2023.1039670. eCollection 2023.
- Background: PubMed 3372671Kitzman JV, Martin JF, Holley JH, Huber WG. Determination of antipyrine in catfish plasma by high-performance liquid chromatography. J Chromatogr. 1988 Mar 11;437(1):306-10. doi: 10.1016/s0021-9673(00)90399-6. No abstract available.
- Background: PubMed 32143963Lin J, Lin LS, Chen DR, Lin KJ, Wang YF, Chang YJ. Indocyanine green fluorescence method for sentinel lymph node biopsy in breast cancer. Asian J Surg. 2020 Dec;43(12):1149-1153. doi: 10.1016/j.asjsur.2020.02.003. Epub 2020 Mar 3.
- Background: PubMed 38097484White KP, Sinagra D, Dip F, Rosenthal RJ, Mueller EA, Lo Menzo E, Rancati A. Indocyanine green fluorescence versus blue dye, technetium-99M, and the dual-marker combination of technetium-99M + blue dye for sentinel lymph node detection in early breast cancer-meta-analysis including consistency analysis. Surgery. 2024 Apr;175(4):963-973. doi: 10.1016/j.surg.2023.10.021. Epub 2023 Dec 13.
- Background: PubMed 35894448Bargon CA, Huibers A, Young-Afat DA, Jansen BAM, Borel-Rinkes IHM, Lavalaye J, van Slooten HJ, Verkooijen HM, van Swol CFP, Doeksen A. Sentinel Lymph Node Mapping in Breast Cancer Patients Through Fluorescent Imaging Using Indocyanine Green: The INFLUENCE Trial. Ann Surg. 2022 Nov 1;276(5):913-920. doi: 10.1097/SLA.0000000000005633. Epub 2022 Jul 27.
- Background: PubMed 29134374Kim WH, Kim HJ, Jung JH, Park HY, Lee J, Kim WW, Park JY, Chae YS, Lee SJ. Ultrasound-Guided Restaging and Localization of Axillary Lymph Nodes After Neoadjuvant Chemotherapy for Guidance of Axillary Surgery in Breast Cancer Patients: Experience with Activated Charcoal. Ann Surg Oncol. 2018 Feb;25(2):494-500. doi: 10.1245/s10434-017-6250-3. Epub 2017 Nov 13.
- Background: PubMed 28830644Kim WH, Kim HJ, Jung JH, Park HY, Lee J, Kim WW, Park JY, Cheon H, Lee SM, Cho SH, Shin KM, Kim GC. Ultrasound-Guided Fine-Needle Aspiration of Non-palpable and Suspicious Axillary Lymph Nodes with Subsequent Removal after Tattooing: False-Negative Results and Concordance with Sentinel Lymph Nodes. Ultrasound Med Biol. 2017 Nov;43(11):2576-2581. doi: 10.1016/j.ultrasmedbio.2017.07.011. Epub 2017 Aug 19.
- Background: PubMed 30470459Lee J, Jung JH, Kim WW, Lee RK, Kim HJ, Kim WH, Park JY, Jeong JY, Chae YS, Lee SJ, Park SH, Kim MY, Yang JD, Lee JW, Lee JS, Park HY. 5-year oncological outcomes of targeted axillary sampling in pT1-2N1 breast cancer. Asian J Surg. 2019 Jun;42(6):681-687. doi: 10.1016/j.asjsur.2018.10.004. Epub 2018 Nov 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeeyeon Lee, Associate professor in Kyungpook National University, MD, PhD contact
Korean Breast Cancer Society Study Group study director
Korean Breast Cancer Society Study Group
Questions about this trial
What is this clinical trial studying?
A study testing Targeting of axillary lymph nodes using LuminoMark and Targeting of axillary lymph nodes using conventional method in people with Breast Cancer and Axillary Lymph Nodes, run by Kyungpook National University Chilgok Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeeyeon Lee, Associate professor in Kyungpook National University, MD, PhD (82-53-200-2707, j.lee@knu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the axillary lymph node targeting method (time frame: From enrollment to the end of observation at 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06903429, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.