Clinical trial · Interventional
MUltimodal Targeted Axillary Surgery
Prospective Trial to Evaluate MUltimodal Targeted Axillary Surgery (MUTAS) Approaches in Breast Cancer Patients With Positive Lymph Nodes.
NCT04039893CI-TRIAL-00054466MUTASunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Node-positive Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Excision of suspicious lymph nodes | Procedure | — | UNRESOLVED |
| Sentinel node | Diagnostic Test | — | UNRESOLVED |
| Systematic axillary ultrasound imaging | Diagnostic Test | — | UNRESOLVED |
| Two steps axillary node clearance | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Node-positive breast cancer patients
- description
- All patients with positive lymph nodes for who an axillary node clearance is proposed as part of the surgical treatment
- interventionNames
- Diagnostic Test: Systematic axillary ultrasound imaging
- Diagnostic Test: Sentinel node
- Procedure: Excision of suspicious lymph nodes
- Procedure: Two steps axillary node clearance
Primary outcomes (3)
- measure
- Number of patients correctly identified as low axillary tumor load carriers by a pre-defined systematic axillary ultrasound imaging workflow
- timeFrame
- 24 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDVernet-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 25657069
- BACKGROUNDNicolau 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 29027318