- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02781259
Selective Lymph Node Dissection Using Fluorescent Dye in Node-positive Breast Cancer
September 18, 2016 updated by: Seok Won Kim, Samsung Medical Center
In this study, navigation of lymphatic passage after sentinel lymph node with indocyanine green was performed during axillary lymph node dissection in breast surgery .
By comparing the concordance between the passage of indocyanine green and actual lymph node metastasis, selective lymph node dissection can be developed.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Low dose of indocyanine green emits near-infrared fluorescence, which can penetrate thin tissues like breast or skin.
The operator can track the lymphatic pathway without skin incision in real time.
By these characteristics, indocyanine green is currently used for sentinel lymph node biopsy in breast cancer surgery.
Indocyanine green can also stain lymph nodes beyond the sentinel lymph nodes.
This is why we can identify the lymphatic metastasis pathway of breast cancer.
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Phase 4
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: SeokWon Kim, MD. PhD.
- Phone Number: +82-2-3410-3479
- Email: seokwon1.kim@samsung.com
Study Locations
-
-
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Seoul, Korea, Republic of, 06351
- Recruiting
- Samsung Medical Center
-
Contact:
- SeokWon Kim, Md. PhD
- Phone Number: +82-2-3410-3479
- Email: seokwon1.kim@samsung.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
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Operable breast cancer patient
- Preoperatively axillary lymph node positive proven patients or sentinel lymph node positive patients whom requires axillary lymph node dissection
Exclusion Criteria:
- Breast cancer history
- Occult breast cancer
- Past history of axillary surgery
- Iodine hypersensitivity
- Pregnancy
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: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Selective Lymph Node Dissection
10cc of 20μg/mL indocyanine green is injected at the nipple-areola complex before surgery.
Routine axillary lymph node dissection is performed.
Acquired lymph nodes are separated to fluorescent positive lymph nodes and fluorescent negative lymph nodes with imaging devices.
|
Lymph node dissection is performed in axillary lymph node level I and II.
In case of palpable nodes in level II, additional lymph node dissection in level III is done.
10cc of 20μg/mL indocyanine green is injected at the nipple-areola complex before surgery
Other Names:
Near-infrared fluorescence is collected by imaging lenses and digital camera.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of metastatic lymph nodes in fluorescent positive lymph nodes and fluorescent negative lymph nodes confirmed by pathologist
Time Frame: within 2 weeks (plus or minus 3 days) after surgery
|
Concordance analysis is done by comparing lymph node metastasis between fluorescent positive lymph nodes and fluorescent negative lymph nodes.
|
within 2 weeks (plus or minus 3 days) after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinicopathological factors associated with lymph node metastasis in fluorescent negative lymph nodes
Time Frame: within 2 weeks (plus or minus 3 days) after surgery
|
Risk factor analysis of fluorescent negative lymph node with positive lymph node metastasis
|
within 2 weeks (plus or minus 3 days) after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: SeokWon Kim, MD. PhD., Samsung Medical Center
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
May 1, 2016
Primary Completion (Anticipated)
February 1, 2017
Study Completion (Anticipated)
April 1, 2017
Study Registration Dates
First Submitted
May 8, 2016
First Submitted That Met QC Criteria
May 23, 2016
First Posted (Estimate)
May 24, 2016
Study Record Updates
Last Update Posted (Estimate)
September 20, 2016
Last Update Submitted That Met QC Criteria
September 18, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-01-046-007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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