Sentinel Lymph Node BiopsyNCT06212440
Clinical Application of Multi-modal Sentinel Lymph Node Staining Method in Breast Cancer Patients After Neoadjuvant Chemotherapy
A study testing Radioactive Isotope (RI) Mapping, Indocyanine Green Fluorescence (ICG-F) Mapping and Vital Dye Mapping in people with Sentinel Lymph Node Biopsy and Neoadjuvant Therapy, run by National Cancer Center, Korea at 2 sites in South Korea.
Trial summary
This clinical trial aimed to confirm the effectiveness of sentinel lymph node surgery by determining the lymph node identification rate using multimodal sentinel lymph node marker methods in patients with advanced breast cancer undergoing neoadjuvant chemotherapy (NAC). Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sentinel Lymph Node Biopsy, Neoadjuvant Therapy, Breast Neoplasm
- What is being tested?
- Radioactive Isotope (RI) Mapping, Indocyanine Green Fluorescence (ICG-F) Mapping and Vital Dye Mapping
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 4 May 2021to 2 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient with locally advanced breast cancer who achieved neoadjuvant chemotherapy
- Confirmed operability with imaging study after neoadjuvant chemotherapy
- Age over 20 years old
- ECOG Performance status : 0-2
- The patient with written informed consent form
Who cannot join
- The patient with previous ipsilateral breast cancer history
- The patinet with previous ipsilateral axillary surgical procedure (e.g. excisional or incisional biopsy, axillary dissection)
- The patient without neoadjuvant chemotherapy
- Inoperable imaging study after neoadjuvant chemotherapy
- Inflammatory breast cancer
- Pregnant patient
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
National cancer center
Goyang-si, Gyeonggi-do, 82
About this study
Official title: Clinical Application of Multi-modal Sentinel Lymph Node Staining Method in Breast Cancer Patients Who Receive Neoadjuvant Chemotherapy : Expanded Access Clinical Study in 3 Arms
This clinical trial aimed to confirm the effectiveness of sentinel lymph node surgery by determining the lymph node identification rate using multimodal sentinel lymph node marker methods in patients with advanced breast cancer undergoing neoadjuvant chemotherapy (NAC).
Read the detailed description
After NAC, the sentinel lymph node (SLN) identification rate is lower, and it has a higher false-negative rate than that in early-stage breast cancer. As appropriate SLN surgery directly affects the treatment and prognosis of patients undergoing NAC, evaluation to identify SLN using various methods is necessary.
This clinical trial aimed to confirm the effectiveness of sentinel lymph node surgery by determining the lymph node identification rate using multimodal sentinel lymph node marker methods in patients with advanced breast cancer undergoing neoadjuvant chemotherapy (NAC).
- Being tested
- Radioactive Isotope (RI) Mapping, Indocyanine Green Fluorescence (ICG-F) Mapping, Vital Dye Mapping
- Keywords
- breast cancer, sentinel node biopsy, neoadjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radioactive Isotope (RI) MappingDiagnostic test
Administered via peritumoral or subareolar injection for sentinel lymph node detection.
Indocyanine Green Fluorescence (ICG-F) MappingDiagnostic test
Administered via peritumoral or subareolar injection, detected using near-infrared fluorescence imaging.
Vital Dye MappingDiagnostic test
Administered via peritumoral or subareolar injection for intraoperative visualization of lymphatic drainage pathways.
| Study group | Role | What they receive |
|---|---|---|
| RI + ICG-F | Experimental | Participants undergo sentinel lymph node biopsy using Radioactive Isotope (RI) and Indocyanine Green Fluorescence (ICG-F) for lymphatic mapping. Receives: Diagnostic Test: Radioactive Isotope (RI) Mapping; Diagnostic Test: Indocyanine Green Fluorescence (ICG-F) Mapping |
| RI + Vital Dye | Experimental | Participants undergo sentinel lymph node biopsy using Radioactive Isotope (RI) and Vital Dye for lymphatic mapping. Receives: Diagnostic Test: Radioactive Isotope (RI) Mapping; Diagnostic Test: Vital Dye Mapping |
| Vital Dye + ICG-F | Experimental | Participants undergo sentinel lymph node biopsy using Vital Dye and Indocyanine Green Fluorescence (ICG-F) for lymphatic mapping. Receives: Diagnostic Test: Indocyanine Green Fluorescence (ICG-F) Mapping; Diagnostic Test: Vital Dye Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification rate of sentinel lymph node
Collection of data for detection rate of sentinel lymph node for each group following direct comparison between each arms.
Measured: during operation
Secondary outcomes (1)
Comparison of operation time for sentinel lymph node biopsy
collection of data for operation time between skin incision and detection of sentinel lymph node, following direct comparison between each arms
Measured: during operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start4 May 2021
- Primary completion14 Aug 2024
- Study completion2 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sentinel Lymph Node BiopsyStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open-label, prospective, single-institution, 3-arms expended randomized study
- Masking
- None (open label)
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Seeyoun Lee, National Cancer Center, Korea
- Investigators
- Seeyoun Lee, Doctor, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212440
- Sponsor's protocol ID
- 2010242-2
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2023
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Multi-modal Sentinel Lymph Node Staining Method in Breast Cancer Patients Who Receive Neoadjuvant Chemotherapy : Expanded Access Clinical Study in 3 Arms
- ClinicalTrials.gov ID
- NCT06212440
- Acronym / sponsor ID
- 2010242-2
- Keywords
- breast cancer, sentinel node biopsy, neoadjuvant chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 4 May 2021 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 18 Jan 2024 (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.
This clinical trial aimed to confirm the effectiveness of sentinel lymph node surgery by determining the lymph node identification rate using multimodal sentinel lymph node marker methods in patients with advanced breast cancer undergoing neoadjuvant chemotherapy (NAC).
Detailed description
After NAC, the sentinel lymph node (SLN) identification rate is lower, and it has a higher false-negative rate than that in early-stage breast cancer. As appropriate SLN surgery directly affects the treatment and prognosis of patients undergoing NAC, evaluation to identify SLN using various methods is necessary.
This clinical trial aimed to confirm the effectiveness of sentinel lymph node surgery by determining the lymph node identification rate using multimodal sentinel lymph node marker methods in patients with advanced breast cancer undergoing neoadjuvant chemotherapy (NAC).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- open-label, prospective, single-institution, 3-arms expended randomized study
| Arm | Type | Receives |
|---|---|---|
| RI + ICG-F | Experimental | Diagnostic Test: Radioactive Isotope (RI) Mapping, Diagnostic Test: Indocyanine Green Fluorescence (ICG-F) MappingParticipants undergo sentinel lymph node biopsy using Radioactive Isotope (RI) and Indocyanine Green Fluorescence (ICG-F) for lymphatic mapping. |
| RI + Vital Dye | Experimental | Diagnostic Test: Radioactive Isotope (RI) Mapping, Diagnostic Test: Vital Dye MappingParticipants undergo sentinel lymph node biopsy using Radioactive Isotope (RI) and Vital Dye for lymphatic mapping. |
| Vital Dye + ICG-F | Experimental | Diagnostic Test: Indocyanine Green Fluorescence (ICG-F) Mapping, Diagnostic Test: Vital Dye MappingParticipants undergo sentinel lymph node biopsy using Vital Dye and Indocyanine Green Fluorescence (ICG-F) for lymphatic mapping. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient with locally advanced breast cancer who achieved neoadjuvant chemotherapy
- Confirmed operability with imaging study after neoadjuvant chemotherapy
- Age over 20 years old
- ECOG Performance status : 0-2
- The patient with written informed consent form
Key exclusion criteria (6 listed)
- The patient with previous ipsilateral breast cancer history
- The patinet with previous ipsilateral axillary surgical procedure (e.g. excisional or incisional biopsy, axillary dissection)
- The patient without neoadjuvant chemotherapy
- Inoperable imaging study after neoadjuvant chemotherapy
- Inflammatory breast cancer
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 |
|---|---|---|
| Radioactive Isotope (RI) MappingAdministered via peritumoral or subareolar injection for sentinel lymph node detection. | Diagnostic test | RI + ICG-F, RI + Vital Dye |
| Indocyanine Green Fluorescence (ICG-F) MappingAdministered via peritumoral or subareolar injection, detected using near-infrared fluorescence imaging. | Diagnostic test | RI + ICG-F, Vital Dye + ICG-F |
| Vital Dye MappingAdministered via peritumoral or subareolar injection for intraoperative visualization of lymphatic drainage pathways. | Diagnostic test | RI + Vital Dye, Vital Dye + ICG-F |
Primary outcome
Identification rate of sentinel lymph node
Time frame: during operation
Collection of data for detection rate of sentinel lymph node for each group following direct comparison between each arms.
1 secondary outcome
Comparison of operation time for sentinel lymph node biopsy
Time frame: during operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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. This study is not recruiting at the moment.
Seeyoun Lee, Doctor principal investigator
National Cancer Center, Korea
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radioactive Isotope (RI) Mapping, Indocyanine Green Fluorescence (ICG-F) Mapping and Vital Dye Mapping in people with Sentinel Lymph Node Biopsy and Neoadjuvant Therapy, run by National Cancer Center, Korea at 2 sites in South Korea.
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 6 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: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification rate of sentinel lymph node (time frame: during operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2025.