NCT04039893

MUltimodal Targeted Axillary Surgery

Prospective Trial to Evaluate MUltimodal Targeted Axillary Surgery (MUTAS) Approaches in Breast Cancer Patients With Positive Lymph Nodes.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Node-positive Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-10-23
• Primary completion: 2022-03-15
• Completion: 2022-11-15
• First posted: 2019-07-31
• Last updated: 2021-10-15

Locations

1 site across 1 country: Spain