NCT04829643

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

March 26, 2025

Status Verified

October 1, 2024

Enrollment Period

4.4 years

First QC Date

March 31, 2021

Last Update Submit

March 23, 2025

Conditions

Breast CancerSentinel Lymph NodeEarly-stage Breast Cancer

Keywords

PET/MRIsentinel node biopsyearly breast cancer

Outcome Measures

Primary Outcomes (1)

  • SNB vs PET/MRI

    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 Outcomes (2)

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

    At 12 months

  • Correlation between PET/MRI parameters and breast cancer prognosis

    0 and 36 months

Study Arms (1)

PET/MRI

EXPERIMENTAL

Patients with early breast cancer up to 3 cm without overt nodal involvement who are candidates to upfront surgery

Diagnostic Test: PET/MRI

Interventions

PET/MRIDIAGNOSTIC_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

PET/MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oreste Davide Gentilini

Milan, MI, 20132, Italy

Location

Related Publications (9)

  • 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: 26291922BACKGROUND

  • Pilewskie M, Jochelson M, Gooch JC, Patil S, Stempel M, Morrow M. Is Preoperative Axillary Imaging Beneficial in Identifying Clinically Node-Negative Patients Requiring Axillary Lymph Node Dissection? J Am Coll Surg. 2016 Feb;222(2):138-45. doi: 10.1016/j.jamcollsurg.2015.11.013. Epub 2015 Nov 25.

    PMID: 26711795BACKGROUND

  • 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: 25112399BACKGROUND

  • 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: 16670863BACKGROUND

  • 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: 25282709BACKGROUND

  • 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: 27023002BACKGROUND

  • 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: 17164229BACKGROUND

  • 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: 28905091BACKGROUND

  • Di Micco R, Botteri E, Canevari C, Gallivanone F, Antunovic L, Scifo P, Neri I, Gelardi F, Magnani P, Losio C, Venturini E, Della Vecchia G, Ferrarese G, Rotmensz N, Zuber V, Baleri S, Cisternino G, Calabretto F, Corona SP, Rampa M, Pitoni L, Scaduto V, Morgante MM, Critelli A, Sassi I, Bianchini G, Panizza P, Chiti A, Gentilini OD. [18F]FDG PET/MRI vs sentinel node biopsy for axillary staging of early breast cancer patients. A prospective single-arm trial. Eur J Cancer. 2025 Jun 25;224:115519. doi: 10.1016/j.ejca.2025.115519. Epub 2025 May 24.

    PMID: 40449294DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • ORESTE D GENTILINI, MD

    Director Breast Unit

    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
Head of Breast Unit, Head of Breast Surgery

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 2, 2021

Study Start

June 1, 2020

Primary Completion

October 30, 2024

Study Completion

October 30, 2024

Last Updated

March 26, 2025

Record last verified: 2024-10

Locations

IT(1)