NCT04826211

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

Completed NA Last updated 1 August 2025

What this trial tests

NA trial testing PET/MRI in Breast Cancer Female in 109 participants. Completed in 31 December 2024.

Timeline

4 November 2019

Primary endpoint
30 April 2024

31 December 2024

Quick facts

Lead sponsor	IRCCS San Raffaele
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	109
Start date	4 November 2019
Primary completion	30 April 2024
Estimated completion	31 December 2024
Sites	1 location across Italy

Drugs / interventions tested

• PET/MRI

Conditions studied

• Breast Cancer Female — all drugs for Breast Cancer Female →
• Node-positive Breast Cancer — all drugs for Node-positive Breast Cancer →
• Sentinel Lymph Node — all drugs for Sentinel Lymph Node →

Sponsor

IRCCS San Raffaele — full company profile →

Who can join

18 and older, any sex, with Breast Cancer Female or Node-positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. PET/MRI for Staging the Axilla in Breast Cancer: Current Evidence and the Rationale for SNB vs. PET/MRI Trials.
   Di Micco R, Santurro L, Gasparri ML, Zuber V, et al · · 2021 · cited 13× · PMID 34298781 · DOI 10.3390/cancers13143571
2. PET/MRI and Novel Targets for Breast Cancer.
   Chung HW, Park KS, Lim I, Noh WC, et al · · 2024 · cited 4× · PMID 38255277 · DOI 10.3390/biomedicines12010172