NCT04932460

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

June 15, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

June 21, 2021

Status Verified

June 1, 2021

Enrollment Period

2.1 years

First QC Date

May 31, 2021

Last Update Submit

June 18, 2021

Conditions

Breast NeoplasmsNeoadjuvant TherapySentinel Lymph Node Biopsy

Keywords

contrast enhanced ultrasonography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • The detective rate of sentinel lymph node biopsy

    6 months

  • The average numbers of sentinel lymph node

    6 months

  • The accuracy of CEUS in evaluation of axillary lymph nodes in breast cancer

    6 months

Study Arms (1)

CEUS+blue dye

EXPERIMENTAL

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.

Procedure: CEUSProcedure: blue dye

Interventions

CEUSPROCEDURE

CEUS is performed before neoadjuvant treatment and surgery to evaluate the status of axillary lymph node and locate the sentinel lymph node.

CEUS+blue dye
blue dyePROCEDURE

Before operation, blue dye is injected for sentinel lymph node mapping.

CEUS+blue dye

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated hospital of Sun Yat-Sen university

Guangzhou, Guangdong, 510000, China

Location

Related Publications (2)

  • 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.

    PMID: 23683750RESULT

  • 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.

    PMID: 25452445RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Ying Lin

CONTACT

13076873871linying3@mail.sysu.edu.cn

Zhen Shan

CONTACT

18565396593szsysu@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Director of Department of Breast Surgery

Study Record Dates

First Submitted

May 31, 2021

First Posted

June 21, 2021

Study Start

June 15, 2021

Primary Completion

July 15, 2023

Study Completion

August 15, 2023

Last Updated

June 21, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)