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

September 27, 2023 updated by: Oreste Davide Gentilini, IRCCS San Raffaele

Targeting the Future of Axillary Staging in Early Breast Cancer: A Comparative Study: Sentinel Node Biopsy 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

247

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • MI
      • Milano, MI, Italy, 20132
        • Recruiting
        • Oreste Davide Gentilini
        • Contact:
        • Contact:
        • Sub-Investigator:
          • ROSA DI MICCO
        • Sub-Investigator:
          • CARLA CANEVARI
        • Sub-Investigator:
          • PIETRO PANIZZA, Co-PI
        • Sub-Investigator:
          • ELENA VENTURINI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • signed Informed Consent
  • age > 18
  • cT < 3 cm
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PET/MRI
Patients with early breast cancer up to 3 cm without overt nodal involvement who are candidates to upfront surgery
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 1 month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 12 months
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.
0 and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Collaborators

IBFM- Consiglio Nazionale delle Ricerche

Investigators

  • Principal Investigator: ORESTE D GENTILINI, MD, Director Breast Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2020

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 14, 2025

Study Registration Dates

First Submitted

March 31, 2021

First Submitted That Met QC Criteria

April 1, 2021

First Posted (Actual)

April 2, 2021

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNBvsPET/MRI 2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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