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MUltimodal Targeted Axillary Surgery

NCT04039893 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-10-15

No results posted yet for this study

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.

Conditions

  • Node-positive Breast Cancer

Interventions

DIAGNOSTIC_TEST

Systematic axillary ultrasound imaging

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.

DIAGNOSTIC_TEST

Sentinel node

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

PROCEDURE

Excision of suspicious lymph nodes

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

PROCEDURE

Two steps axillary node clearance

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.

Sponsors & Collaborators

  • GEICAM

    collaborator UNKNOWN

  • Parc de Salut Mar

    lead OTHER

Principal Investigators

  • Maria Vernet-Tomas, MD, PhD · Parc de Salut Mar

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-23
Primary Completion
2022-03-15
Completion
2022-11-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04039893 on ClinicalTrials.gov