Contrast-enhanced Ultrasonography Combined With Blue Dye as Dual-tracer for Sentinel Lymph Node Biopsy

Breast Neoplasms Clinical Trial

— Asclepius  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04932460
• Other study ID #: 2021332GD
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2021
• Est. completion date: August 15, 2023

Study information

• Verified date: June 2021
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Ying Lin
• Phone: 13076873871
• Email: linying3[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: August 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoadjuvant Therapy
• Sentinel Lymph Node Biopsy

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	The first affiliated hospital of Sun Yat-Sen university	Guangzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University	First Affiliated Hospital of Shantou University Medical College, The Affiliated Hospital of Guangdong Medical College, The Seventh Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (2)

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 neoadju — View 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 chemot — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	False negative rate	The false negative rate (FNR) of sentinel lymph node biopsy using dual-tracer with CEUS and blue dye after neoadjuvant chemotherapy in invasive breast cancer patients.; The FNR is calculated as the number of false negative cases divided by the number of false negative plus true positive cases and then multiplied by 100%.	6 months
Secondary	The detective rate of sentinel lymph node biopsy	The detective rate of SLNB after neoadjuvant therapy when using blue dye and CEUS lymphatic mapping as dual tracer.; The detective rate is calculated as the number of patients in whom SLN can be detected during SLNB divided by the number of patients with the treatment of SLNB and then multiplied by 100%.	6 months
Secondary	The average numbers of sentinel lymph node	The average numbers of sentinel lymph node is calculated as the number of all SLNs detected during SLNB divided by the number of patients received SLNB and then multiplied by 100%.	6 months
Secondary	The accuracy of CEUS in evaluation of axillary lymph nodes in breast cancer	The accuracy of CEUS in evaluation of axillary lymph nodes in breast cancer patients before and after neoadjuvant therapy.; The accuracy rate is calculated as the number of true positive plus true negative cases divided by the number of patients then multiplied by 100%.	6 months