Clinical trial NCT04932460: Contrast-enhanced Ultrasonography Combined With Blue Dye as Dual-tracer for Sentinel Lymph Node Biopsy
Official title: A Prospective Multi-center Study: Contrast-enhanced Ultrasonography Combined With Blue Dye as Dual-tracer for Sentinel Lymph Node Biopsy After Neoadjuvant Therapy in Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasms
Neoadjuvant Therapy
Sentinel Lymph Node Biopsy
Keywords: contrast enhanced ultrasonography
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: The Seventh Affiliated Hospital of Sun Yat-sen University
name: Affiliated Hospital of Guangdong Medical University
name: First Affiliated Hospital of Shantou University Medical College
First posted: 2021-06-21
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: False negative rate (FNR) in patients who has accepted neoadjuvant therapy is high. Blue dye and radioisotope as dual-tracer can decrease FNR. Several large clinical trials showed that using dual trace with blue dye and radioisotope can reduce the FNR to less than 10%. But radioisotope is still not approved in China and can cause radiocontamination. A novel dual-tracer which can decrease the FNR in patients after neoadjuvant therapy is urged to be explored. Contrast enhanced ultrasonography (CEUS) can make the lymphatic drainage path and sentinel lymph nodes visible. Retrospective studies found that CEUS can locate SLN precisely. So this clinical trial aim to evaluate FNR, detective rate and numbers of SLN by using CEUS combined with blue dye as dual-tracer in sentinel lymph node biopsy in breast cancer patients after neoadjuvant therapy and the accuracy of CEUS for the diagnosis of lymph node metastasis before and after neoadjuvant therapy.


Eligibility criteria: Inclusion Criteria:

* ≥18 years old female；
* ECOG：0 - 1；
* Biopsy confirmed invasive breast cancer；
* cT1-4N0-3；
* Signed informed consent.

Exclusion Criteria:

* Inflammatory breast cancer；
* Received ipsilateral axillary surgery previously；
* During pregnancy.

Primary outcomes:
measure: False negative rate
timeFrame: 6 months
Secondary outcomes:
measure: The detective rate of sentinel lymph node biopsy
timeFrame: 6 months
measure: The average numbers of sentinel lymph node
timeFrame: 6 months
measure: The accuracy of CEUS in evaluation of axillary lymph nodes in breast cancer
timeFrame: 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The first affiliated hospital of Sun Yat-Sen university
state: Guangdong
Study officials:
References:
citation: 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.
citation: 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.