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

NCT04826211 | Completed

• 1 other identifier: SNB vs PET/MRI 1
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer Female; Node-positive Breast Cancer; Sentinel Lymph Node

Keywords

primary systemic therapy; node positive breast cancer; surgery after primary systemic therapy; PET/MRI

Outcome Measures

Primary Outcomes (1)

• Axillary surgery vs 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 Outcomes (2)

• Staging power of PET/MRI will be compared to preoperative A-US (Axillary ultrasound)

  At 12 months

• Correlation between PET/MRI parameters and prognosis

  At baseline and at 5 years

Study Arms (1)

Node positive BC patients undergoing PST

EXPERIMENTAL

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

Interventions

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).

Node positive BC patients undergoing PST

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy: collaborator

Study Sites (1)

Ospedale San Raffaele

Milan, MI, 20132, Italy

Location

Related Publications (7)

• Taneja S, Jena A, Goel R, Sarin R, Kaul S. Simultaneous whole-body (1)(8)F-FDG PET-MRI in primary staging of breast cancer: a pilot study. Eur J Radiol. 2014 Dec;83(12):2231-2239. doi: 10.1016/j.ejrad.2014.09.008. Epub 2014 Sep 28.

  PMID: 25282709 BACKGROUND

• Melsaether AN, Raad RA, Pujara AC, Ponzo FD, Pysarenko KM, Jhaveri K, Babb JS, Sigmund EE, Kim SG, Moy LA. Comparison of Whole-Body (18)F FDG PET/MR Imaging and Whole-Body (18)F FDG PET/CT in Terms of Lesion Detection and Radiation Dose in Patients with Breast Cancer. Radiology. 2016 Oct;281(1):193-202. doi: 10.1148/radiol.2016151155. Epub 2016 Mar 29.

  PMID: 27023002 BACKGROUND

• Veronesi U, De Cicco C, Galimberti VE, Fernandez JR, Rotmensz N, Viale G, Spano G, Luini A, Intra M, Veronesi P, Berrettini A, Paganelli G. A comparative study on the value of FDG-PET and sentinel node biopsy to identify occult axillary metastases. Ann Oncol. 2007 Mar;18(3):473-8. doi: 10.1093/annonc/mdl425. Epub 2006 Dec 12.

  PMID: 17164229 BACKGROUND

• Gentilini O, Veronesi U. Staging the Axilla in Early Breast Cancer: Will Imaging Replace Surgery? JAMA Oncol. 2015 Nov;1(8):1031-2. doi: 10.1001/jamaoncol.2015.2337. No abstract available.

  PMID: 26291922 BACKGROUND

• van Nijnatten TJA, Goorts B, Voo S, de Boer M, Kooreman LFS, Heuts EM, Wildberger JE, Mottaghy FM, Lobbes MBI, Smidt ML. Added value of dedicated axillary hybrid 18F-FDG PET/MRI for improved axillary nodal staging in clinically node-positive breast cancer patients: a feasibility study. Eur J Nucl Med Mol Imaging. 2018 Feb;45(2):179-186. doi: 10.1007/s00259-017-3823-0. Epub 2017 Sep 14.

  PMID: 28905091 BACKGROUND

• Heusch P, Nensa F, Schaarschmidt B, Sivanesapillai R, Beiderwellen K, Gomez B, Kohler J, Reis H, Ruhlmann V, Buchbender C. Diagnostic accuracy of whole-body PET/MRI and whole-body PET/CT for TNM staging in oncology. Eur J Nucl Med Mol Imaging. 2015 Jan;42(1):42-8. doi: 10.1007/s00259-014-2885-5. Epub 2014 Aug 12.

  PMID: 25112399 BACKGROUND

• Stadnik TW, Everaert H, Makkat S, Sacre R, Lamote J, Bourgain C. Breast imaging. Preoperative breast cancer staging: comparison of USPIO-enhanced MR imaging and 18F-fluorodeoxyglucose (FDC) positron emission tomography (PET) imaging for axillary lymph node staging--initial findings. Eur Radiol. 2006 Oct;16(10):2153-60. doi: 10.1007/s00330-006-0276-4. Epub 2006 May 3.

  PMID: 16670863 BACKGROUND

Study Officials

• GENTILINI

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: April 1, 2021
• Study Start: November 4, 2019
• Primary Completion: April 30, 2024
• Study Completion: December 31, 2024
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)