MUltimodal Targeted Axillary Surgery (MUTAS)

  • STATUS
    Recruiting
  • days left to enroll
    40
  • participants needed
    160
  • sponsor
    Parc de Salut Mar
Updated on 19 February 2022

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.

Description

Axillary node clearance (ANC) is a controversial intervention in the surgical treatment of breast cancer. Different studies have shown that in some patients with infiltrated axillary lymph nodes but low tumor burden, ANC can be safely omitted. However, indications for ANC persist in nowadays for patients with positive axillary lymph nodes and upfront surgery and patients with positive lymph nodes after neoadjuvant treatment. The present prospective study will evaluate the ability to establish an axillary tumor load with two steps. The first step will be a preoperative predefined systematic axillary ultrasound imaging workflow. The second step will be the tumor load evaluation of suspicious and sentinel axillary lymph nodes. We will also evaluate which patients have infiltrated nodes only beneath the second intercostobrachial nerve. The trial intends to identify patients for who a complete axillary node clearance could be spared.

Details
Condition Node-positive Breast Cancer
Treatment Systematic axillary ultrasound imaging, Sentinel node, Sentinel node, Excision of suspicious lymph nodes, Two steps axillary node clearance
Clinical Study IdentifierNCT04039893
SponsorParc de Salut Mar
Last Modified on19 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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