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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04932460
Other study ID # 2021332GD
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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