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NCT Number: NCT04829643

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Early-Stage Breast Cancer Neoplasms Neoplasms by Site Sentinel Lymph Node Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oreste Davide Gentilini

Milan, MI, 20132, Italy

About this study

SNB is the gold standard for axillary staging in early BC patients. Although being a minimally invasive, it is time consuming both for surgeon and pathologist, it may add a further scar and is not free from complications: seroma, limitation of shoulder movement, nerve injury, lymphedema. To date, patients undergoing breast conserving surgery (BCS) with 1 to 2 positive nodes can be treated with SNB alone (ACOSOG Z011 trial NCT00003855[2-4]) and researchers are evaluating within large randomized trials to even omit surgery at all when axillary imaging is negative (SOUND (Sentinel node biopsy vs Observation after axillary Ultra-souND), PI and Study Chair Dr.O.Gentilini,MD, NCT02167490 and INSEMA (Intergroup-SEntinel-MAmma) trial NCT02466737.

While the role of surgery is decreasing, the role of preoperative imaging is increasing. In the future, imaging might even replace surgery in the axillary staging of BC patients, still providing an appropriate level of information to guide medical treatments which are more and more tailored on biology rather than on nodal status. In this context, an unmet need is to achieve the most accurate preoperative imaging assessment of the axilla in order to decide the appropriate treatment for each patient.

The hypothesis of this project is that PET/MRI might provide a single, one-stage, non-invasive, operator independent imaging modality in patients with small BC allowing to select the proper treatment for patients. PET/MRI is a relatively new imaging tool and its field of application is still object of scientific speculation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • signed Informed Consent
  • age > 18
  • non palpable lymph nodes
  • no suspicious nodes at A-US (Axillary- ultrasound)
  • candidate to mastectomy or breast conserving surgery and BLS (Sentinel Node Biopsy)

Exclusion criteria

  • pregnancy
  • distant metastasis
  • inflammatory cancer
  • claustrophobia
  • allergy to contrast agent
  • severe renal insufficiency

Treatment and study plan

PET/MRI

Diagnostic Test

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

Primary outcomes

  1. SNB vs PET/MRI

    Time frame: Within 1 month after surgery

    Results from SNB will be compared to results from PET/MRI y results from SNB will be available and compared to results of preoperative PET/MRI

Secondary outcomes

  1. A secondary outcome is the staging power of PET/MRI compared to preoperative A-US (Axillary Ultrasound)

    Time frame: At 12 months

    Study will focus on a subgroup of patients having one or two uncertain but no suspicious axillary nodes for which SNB is still indicated. Patient population will be divided into two cohorts: those with completely normal axillary lymph node at A-US and those with 1-2 axillary nodes with uncertain ultrasound features. These two groups will be analysed independently. The PET/MRI and A-US results will be compared to each other and ultimately to final pathology, calculating the concordance rate in terms of positive versus negative nodes and number of positive nodes detected by each method. The staging power of both preoperative exams will be evaluated by considering how many times the results from PET/MRI or A-US could have indicated the most appropriate axillary treatment according to pathological findings.

  2. Correlation between PET/MRI parameters and breast cancer prognosis

    Time frame: 0 and 36 months

    Eventual associations between PET/MRI morphological and functional parameters with tumour prognostic features will be investigated.

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Collaborators

  • IBFM- Consiglio Nazionale delle Ricerche

Registry information

Official study title

Targeting the Future of Axillary Staging in Early Breast Cancer: A Comparative Study: Sentinel Node Biopsy vs PET/MRI

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Apr 2, 2021
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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