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Axillary Staging in Node Positive Breast Cancer Patients Receiving PST. SNB vs PET/MRI

NCT04826211 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2025-08-01

No results posted yet for this study

Summary

The management of axillary nodes in breast cancer patients is a highly debated and evolving field. To date, an increasing number of patients with positive lymph nodes receives primary systemic therapy (PST) prior to surgery leading to down-staging axillary nodes in about 40% of women. However, the available diagnostic methods have several limitations in properly evaluating the response after treatment both in the breast and in the nodes and might lead to either under or over-treatment in these patients. Fully integrated scanners capable of simultaneous acquisition of PET and MRI have now been developed, with the potential to combine the specificity obtained by the functional imaging of PET, with the superior sensitivity of MRI, to provide higher diagnostic accuracy.

It is expected that PET/MRI could better determine the response after PST to distinguish patients with negative versus patients with positive axillary nodes after medical treatment. As the excision of axillary nodes has mainly a staging purpose, the reliable identification of node negative patients might eventually spare women from unnecessary surgery. An accurate over-time and final imaging work-up might help choose the appropriate type of surgery according to the extent of nodal involvement: either SNB or complete axillary clearance.

Conditions

  • Breast Cancer Female
  • Node-positive Breast Cancer
  • Sentinel Lymph Node

Interventions

DIAGNOSTIC_TEST

PET/MRI

All included patients will undergo PET/MRI both prior to PST and prior to surgery. In order to analyze results the population will be divided into two groups: women with positive axillary lymph nodes after PST (Group 1) and women with negative axillary lymph nodes after PST (Group 2).

Sponsors & Collaborators

  • Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

    collaborator OTHER_GOV

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • GENTILINI · IRCCS San Raffaele

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-04
Primary Completion
2024-04-30
Completion
2024-12-31

Countries

  • Italy

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 NCT04826211 on ClinicalTrials.gov