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Axillary Staging in Early Breast Cancer: SNB vs PET/MRI

NCT04829643 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2025-03-26

No results posted yet for this study

Summary

The gold standard of surgical treatment for patients with early breast cancer (BC) is breast conservation and sentinel node biopsy (SNB). Ongoing randomized trials are evaluating to omit surgery at all when axillary imaging is negative. However, the available diagnostic tools still have several limitations in accuracy.

Combining the specificity of PET, with the superior sensitivity of MRI, hybrid PET/MRI might be a non-invasive, one-stage, operator-independent imaging method to accurately define nodal status and, whenever negative, might replace surgery for axillary staging.

The project includes patients with \<3 cm BC without overt nodal involvement who will undergo PET/MRI prior to surgery. The primary aim is to compare the staging power between SNB and PET/MRI in detecting axillary lymph node macrometastases (\>2 mm). Additionally, general concordance and diagnostic accuracy of PET/MRI vs SNB, eventual correlation with BC molecular subtypes and MRI findings will be evaluated.

Conditions

Interventions

DIAGNOSTIC_TEST

PET/MRI

A consecutive cohort of 247 patients with early BC and no suspicious nodes at both clinical and A-US evaluations and candidates to upfront surgery and SNB will be recruited

Sponsors & Collaborators

  • IBFM- Consiglio Nazionale delle Ricerche

    collaborator UNKNOWN

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • ORESTE D GENTILINI, MD · Director Breast Unit

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2024-10-30
Completion
2024-10-30

Countries

  • Italy

Study Locations

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Entities

Diseases

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 NCT04829643 on ClinicalTrials.gov