- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06212440
Clinical Application of Multi-modal Sentinel Lymph Node Staining Method in Breast Cancer Patients After Neoadjuvant Chemotherapy
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Seeyoun Lee, Doctor
- Phone Number: 1736 +82-31-920-1736
- Email: seeyoun@ncc.re.kr
Study Locations
-
-
Gyeonggi
-
Goyang, Gyeonggi, Korea, Republic of, 82
- Recruiting
- National Cancer Center
-
Contact:
- Seeyoun Lee, Doctor
- Phone Number: 1736 +82-31-920-1736
- Email: seeyoun@ncc.re.kr
-
-
Gyeonggi-do
-
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
- Recruiting
- National Cancer Center
-
Contact:
- Seeyoun Lee
- Phone Number: 1736 +82-31-920-1736
- Email: seeyoun@ncc.re.kr
-
Contact:
- Kwideuk Son
- Phone Number: 0848 +82-31-920-0848
- Email: 75095@ncc.re.kr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Sentinel LN biopsy by mapping with Radioactive isotope(RI) and Indocyanine Green Fluorescence (ICG-F)
|
Direct comparison of identification rate between A arm and B arm, A arm and C arm.
|
Experimental: B
Sentinel LN biopsy by mapping with Radioactive isotope(RI) and vital dye
|
Direct comparison of identification rate between A arm and B arm, A arm and C arm.
|
Experimental: C
Sentinel LN biopsy by mapping with vital dye and Fluorescence (ICG-F)
|
Direct comparison of identification rate between A arm and B arm, A arm and C arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
during operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of operation time for sentinel lymph node biopsy
Time Frame: during operation
|
collection of data for operation time between skin incision and detection of sentinel lymph node, following direct comparison between each arms
|
during operation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Seeyoun Lee, Doctor, National Cancer Center, Korea
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010242-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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