Contrast-enhanced Ultrasonography Combined With Blue Dye as Dual-tracer for Sentinel Lymph Node Biopsy
NCT ID: NCT04932460
Last Updated: 2021-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
350 participants
INTERVENTIONAL
2021-06-15
2023-08-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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CEUS+blue dye
The included patients will accept essential tests and CEUS before and after neoadjuvant chemotherapy to evaluate axillary lymph nodes status. When patients finish neoadjuvant therapy, SLNB with or without axillary lymph node dissection will be performed using CEUS lymphatic mapping to mark SLN on the skin combined with blue dye.
CEUS
CEUS is performed before neoadjuvant treatment and surgery to evaluate the status of axillary lymph node and locate the sentinel lymph node.
blue dye
Before operation, blue dye is injected for sentinel lymph node mapping.
Interventions
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CEUS
CEUS is performed before neoadjuvant treatment and surgery to evaluate the status of axillary lymph node and locate the sentinel lymph node.
blue dye
Before operation, blue dye is injected for sentinel lymph node mapping.
Eligibility Criteria
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Inclusion Criteria
* ECOG：0 - 1；
* Biopsy confirmed invasive breast cancer；
* cT1-4N0-3；
* Signed informed consent.
Exclusion Criteria
* Received ipsilateral axillary surgery previously；
* During pregnancy.
18 Years
FEMALE
No
Sponsors
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The Seventh Affiliated Hospital of Sun Yat-sen University
OTHER
Affiliated Hospital of Guangdong Medical University
OTHER
First Affiliated Hospital of Shantou University Medical College
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Ying Lin
Vice Director of Department of Breast Surgery
Locations
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The first affiliated hospital of Sun Yat-Sen university
Guangzhou, Guangdong, China
Countries
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Central Contacts
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References
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Kuehn T, Bauerfeind I, Fehm T, Fleige B, Hausschild M, Helms G, Lebeau A, Liedtke C, von Minckwitz G, Nekljudova V, Schmatloch S, Schrenk P, Staebler A, Untch M. Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA): a prospective, multicentre cohort study. Lancet Oncol. 2013 Jun;14(7):609-18. doi: 10.1016/S1470-2045(13)70166-9. Epub 2013 May 15.
Boileau JF, Poirier B, Basik M, Holloway CM, Gaboury L, Sideris L, Meterissian S, Arnaout A, Brackstone M, McCready DR, Karp SE, Trop I, Lisbona A, Wright FC, Younan RJ, Provencher L, Patocskai E, Omeroglu A, Robidoux A. Sentinel node biopsy after neoadjuvant chemotherapy in biopsy-proven node-positive breast cancer: the SN FNAC study. J Clin Oncol. 2015 Jan 20;33(3):258-64. doi: 10.1200/JCO.2014.55.7827. Epub 2014 Dec 1.
Other Identifiers
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2021332GD
Identifier Type: -
Identifier Source: org_study_id
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