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

May 29, 2024 updated by: Oreste Davide Gentilini

Targeting the Future of Axillary Staging in Node Positive Breast Cancer Patients Receiving Primary Systemic Therapy. A Comparative Study Between Sentinel Node Biopsy vs PET/MRI.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

HYPOTHESIS: Hybrid PET/MRI might be a non-invasive, one-stage, operator-independent imaging modality to accurately define nodal status after PST, properly select type of surgical approach and might eventually lead to the omission of axillar surgery in some breast cancer patients showing complete imaging response.

AIMS: The primary endpoint is to compare the staging power between SNB (or lymphoadenectomy) vs PET/MRI in detecting axillary lymph node macro-metastases (>2 mm).Additionally the PET/MRI and A-US results will be confronted and ultimately related to pathology result, calculating the concordance rate in terms of positive vs 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.

EXPERIMENTAL DESIGN: Patients with breast cancer of any size with positive axillary nodes and candidates to PST will undergo PET/MRI prior to PST.

The study population will then be split into two groups:

  • women with positive axillary lymph nodes after PST (Group 1, 60% of the total)
  • women with negative axillary lymph nodes after PST (Group 2, 40% of the total).

A total of 110 women will guarantee two well-powered independent analysis. one for Group 1 (n=66; power>90%; Type I error rate of 0.05) and one for Group 2 (n=44; power>80%; Type I error rate of 0.05).

Study Type

Interventional

Enrollment (Estimated)

110

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
        • Ospedale San Raffaele
        • Sub-Investigator:
          • ROSA DI MICCO
        • Sub-Investigator:
          • CARLA CANEVARI
        • Sub-Investigator:
          • ELENA VENTURINI
        • Contact:
        • Sub-Investigator:
          • LUIGI GIANOLLI
        • Sub-Investigator:
          • PIETRO PANIZZA
        • Sub-Investigator:
          • CLAUDIO LOSIO
        • Sub-Investigator:
          • ZUBER VERONICA
        • Sub-Investigator:
          • ANNARITA SAVI

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 years;
  • Proven diagnosis of early BC of any size;
  • Patients candidate to primary systemic therapy (PST);
  • Positive axillary nodes at diagnosis, confirmed by either citology or histology confirmation. Patients with clear overt clinical and radiological nodal involvement might be enrolled as well without FNA or microhystology

Exclusion Criteria:

  • inflammatory BC;
  • pregnancy;
  • contraindication to PET;
  • distant metastases;
  • no surgery after PST;
  • contraindication to MRI;
  • claustrophobia;
  • allergy to the MR 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: Node positive BC patients undergoing PST
Patients with breast cancer of any size with positive axillary nodes and candidates to PST will undergo PET/MRI both prior to PST and after PST before surgery
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Axillary surgery vs PET/MRI.
Time Frame: Within 1 month after surgery results from axillary surgery will be available and compared to preoperative PET/MRI
Results from SNB (Sentinel Node Biopsy), AD (Axillary Dissection) or any axillary surgery will be compared to results from preoperative PET/MRI.
Within 1 month after surgery results from axillary surgery will be available and compared to preoperative PET/MRI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Staging power of PET/MRI will be compared to preoperative A-US (Axillary ultrasound)
Time Frame: At 12 months
Results on the status of axillary nodes from preoperative A-US will be compared to results of preoperative PET/MRI.
At 12 months
Correlation between PET/MRI parameters and prognosis
Time Frame: At baseline and at 5 years

Quantitative analysis of PET/MRI exams will allow to extract standard imaging biomarkers to be correlated with tumour clinical and pathological data. Image analysis will be carried out both at staging and at the end of PST.

Functional parameters from PET image analysis include Standardized Uptake Value and Metabolic Tumor Volume.

From breast MR images, the quantitative and semiquantitative data are related to DWI and DCE MR sequences. Specifically, from the so-called Time Intensity Curve (TIC) obtained from the dynamic DCE some parameters can be extracted, for example Time To Peak, Peak Enhancement Percentage, Signal Enhancement Ratio and Initial Enhancement Percentage. From DWI MR sequence Apparent Diffusion Coefficient map can be calculated.
At baseline and at 5 years

Collaborators and Investigators

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

Sponsor

Oreste Davide Gentilini

Collaborators

IBFM- Consiglio Nazionale delle Ricerche

Investigators

  • Principal Investigator: GENTILINI, IRCCS San Raffaele

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)

November 4, 2019

Primary Completion (Actual)

April 30, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 25, 2020

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

May 30, 2024

Last Update Submitted That Met QC Criteria

May 29, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNB vs PET/MRI 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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