Selective Lymph Node Dissection Using Fluorescent Dye in Node-positive Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02781259|
Recruitment Status : Unknown
Verified September 2016 by Seok Won Kim, Samsung Medical Center.
Recruitment status was: Recruiting
First Posted : May 24, 2016
Last Update Posted : September 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Procedure: Axillary lymph node dissection Drug: Indocyanine green Device: Imaging devices||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Selective Lymph Node Dissection Using Fluorescent Dye in Node-positive Breast Cancer|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||February 2017|
|Estimated Study Completion Date :||April 2017|
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.
Procedure: Axillary lymph node dissection
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.
Drug: Indocyanine green
10cc of 20μg/mL indocyanine green is injected at the nipple-areola complex before surgery
Other Name: Diagnogreen
Device: Imaging devices
Near-infrared fluorescence is collected by imaging lenses and digital camera.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781259
|Contact: SeokWon Kim, MD. PhD.||+firstname.lastname@example.org|
|Korea, Republic of|
|Samsung medical center||Recruiting|
|Seoul, Korea, Republic of, 06351|
|Contact: SeokWon Kim, Md. PhD +82-2-3410-3479 email@example.com|
|Principal Investigator:||SeokWon Kim, MD. PhD.||Samsung Medical Center|