NCT04039893

Brief Summary

The present trial will prospectively evaluate the accuracy of both a systematic predefined axillary ultrasound imaging together with tumor load quantification of suspicious and sentinel axillary lymph nodes to predict overall tumor load in the axilla.

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
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

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

June 19, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 23, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

2.4 years

First QC Date

June 19, 2019

Last Update Submit

October 14, 2021

Conditions

Node-positive Breast Cancer

Keywords

axillary node clearanceaxillary ultrasound imagingsentinel nodetumor load

Outcome Measures

Primary Outcomes (3)

  • Number of patients correctly identified as low axillary tumor load carriers by a pre-defined systematic axillary ultrasound imaging workflow

    The accuracy (in terms of sensibility, specificity, positive predictive value and negative predictive value) of the pre-defined systematic ultrasound imaging workflow for identifying patients wih low axillary tumor load will be reported. Low axillary tumor load is defined as two or less infiltrated axillary lymph nodes.

    24 months

  • Number of patients correctly identified as low axillary tumor load carriers by the information on tumor load of suspicious and sentinel axillary lymph nodes.

    The accuracy (in terms of sensibility, specificity, positive predictive value and negative predictive value) of different tumor load cut-off points of the suspicious and sentinel axillary lymph nodes for identifying patients with low axillary tumor load will be reported.Low axillary tumor load is defined as two or less infiltrated axillary lymph nodes.

    24 months

  • Number of patients correctly identified as low axillary tumor load carriers combining both the pre-defined axillary ultrasound imaging workflow with the information on tumor load of suspicious and sentinel axillary nodes

    The accuracy (in terms of sensibility, specificity, positive predictive value and negative predictive value) of both the pre-defined systematic axillary ultrasound imaging workflow combined with tumor load information of suspicious and sentinel axillary lymph nodes for identifying patients with low axillary tumor load will be reported.Low axillary tumor load is defined as two or less infiltrated axillary lymph nodes.

    24 months

Secondary Outcomes (7)

  • Number of infiltrated axillary lymph nodes detected by physical exploration

    24 months

  • Number of infiltrated lymph nodes detected by computed tomography

    24 months

  • Number of infiltrated lymph nodes detected by magnetic resonance

    24 months

  • Number of patients with low axillary tumor load among menopause status categories

    24 months

  • Number of patients with low axillary tumor load among each breast cancer pathology subtype.

    24 months

  • +2 more secondary outcomes

Study Arms (1)

Node-positive breast cancer patients

OTHER

All patients with positive lymph nodes for who an axillary node clearance is proposed as part of the surgical treatment

Diagnostic Test: Systematic axillary ultrasound imagingDiagnostic Test: Sentinel nodeProcedure: Excision of suspicious lymph nodesProcedure: Two steps axillary node clearance

Interventions

Systematic axillary ultrasound imagingDIAGNOSTIC_TEST

Before surgery, all patients will be explored with a pre-defined systematic and reproducible axillary ultrasound imaging workflow intending to establish the number of neoplastic lymph nodes.

Node-positive breast cancer patients
Sentinel nodeDIAGNOSTIC_TEST

Sentinel nodes will be identified with a radioisotope tracer and blue dye or fluorescein.

Node-positive breast cancer patients
Excision of suspicious lymph nodesPROCEDURE

Nodes suspected to be infiltrated both by physical exploration and/or ultrasound will be excised and evaluated separately.

Node-positive breast cancer patients
Two steps axillary node clearancePROCEDURE

Axillary node clearance will be performed in two steps comprising inferior and superior clearance. The second intercostobrachial nerve will be considered the limit defining the border between superior and inferior axilla.

Node-positive breast cancer patients

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Node-positive breast cancer patients confirmed by biopsy or cytology
  • Positivity confirmed before the surgical treatment

You may not qualify if:

  • Inability to confirm positive lymph nodes by biopsy or cytology
  • Inability to understand the protocol design
  • Poor understanding of the Spanish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

Related Publications (2)

  • Vernet-Tomas M, Banos N, Sabadell D, Corominas JM, Mestre-Fusco A, Suarez-Pinera M, Carreras R. p53 expression in breast cancer predicts tumors with low probability of non-sentinel nodes infiltration. J Obstet Gynaecol Res. 2015 Jul;41(7):1115-21. doi: 10.1111/jog.12670. Epub 2015 Feb 6.

    PMID: 25657069BACKGROUND

  • Nicolau P, Gamero R, Rodriguez-Arana A, Plancarte F, Alcantara R, Carreras R, Sabadell D, Vernet-Tomas M. Imaging and pathology features to predict axillary tumor load in breast cancer. J Obstet Gynaecol Res. 2018 Feb;44(2):331-336. doi: 10.1111/jog.13490. Epub 2017 Oct 13.

    PMID: 29027318BACKGROUND

MeSH Terms

Interventions

Sentinel Lymph Node Biopsy

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeLymph Node ExcisionInvestigative Techniques

Study Officials

  • Maria Vernet-Tomas, MD, PhD

    Parc de Salut Mar

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Vernet-Tomas, MD, PhD

CONTACT

34932483132mvernet@psmar.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2019

First Posted

July 31, 2019

Study Start

October 23, 2019

Primary Completion

March 15, 2022

Study Completion

November 15, 2022

Last Updated

October 15, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)