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NCT Number: NCT04826211

Axillary Staging in Node Positive Breast Cancer Patients Receiving PST. SNB 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.

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Key information

Conditions

Breast Cancer Female Node-positive Breast Cancer Sentinel Lymph Node

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale San Raffaele

Milan, MI, 20132, Italy

About this study

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).

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 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.

Treatment and study plan

PET/MRI

Diagnostic Test

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Collaborators

  • Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Registry information

Official study title

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.

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Apr 1, 2021
Registry last updated
Aug 1, 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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