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RecruitingNCT05982496FESTAUpdated Jun 12, 2026

18F FES-PET/MRI for Tailoring Treatment of Luminal A and Lobular Breast Cancer

A Phase 2 interventional study of FES and PET/MRI A in Breast Cancer Female, Lobular Breast Carcinoma and PET/MRI, sponsored by Università Vita-Salute San Raffaele. Recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Università Vita-Salute San Raffaele · Phase 2, Interventional, and Diagnostic

Phase
Phase 2
Study type
Interventional
Enrollment
119
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

Study hypothesis is that combining the advantages of hybrid PET/MRI and the high sensitivity/specificity of 16-alpha-18F-fluoro-17-beta-estradiol(FES), a radiolabeled form of estrogen binding to functionally active ER, the investigators could obtain a reliable, non-invasive, operator-independent, one-stage imaging method for staging LumA and ER-positive Lobular tumours.

Read the detailed description

This is a single-centre prospective cohort study where patients with LumA and ER-positive Lob will be enrolled in 1 cohort undergoing: primary surgery; . Aim : Evaluating the performance of FES PET/MRI in axillary staging compared with axillary surgery. Additionally, biological determinants of tumor heterogeneity will be investigated.

02

Conditions studied

  • Breast Cancer Female
  • Lobular Breast Carcinoma
  • PET/MRI
  • Axillary Lymphadenopathy
  • Luminal A Breast Cancer

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Female patients, age>= 18 yrs, diagnosed with primary or advanced breast cancer

  • LumA or ER-positive Lobular subtypes

    • candidates to surgery as first treatment regardless of cN
    • ER-positive Her2 negative BC with ki67>10%

Exclusion criteria

Exclusion Criteria:

  • ER-negative tumors
  • Pregnancy;
  • Contraindication to PET;
  • Contraindication to MRI;
  • Claustrophobia;
  • Allergy to the MR contrast agent;
  • Severe renal insufficiency
04

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
119 participants (estimated)

Study arms

  • Experimental
    Cohort A

    * Candidates to surgery as first treatment regardless of cN * ER+ Her2 negative BC with ki67\>10%

    Drug: FES · Procedure: PET/MRI A · Genetic: Translational analysis

Interventions

  • DrugFES

    16-alpha-18F-fluoro-17-beta-estradiol(FES) is a radiolabeled form of estrogen binding to functionally active ER which will be used as radiotracer for the PET/MRI exam

  • ProcedurePET/MRI A

    An additional FES PET/MRI will be performed before surgery.

  • GeneticTranslational analysis

    Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.

05

What researchers measure

Primary outcomes

  1. Sensitivity of FES PET/MRI in detecting macrometastatic axillary lymph nodes

    Ability of FES PET/MRI to detect macrometastatic (tumor deposit\>2mm) axillary lymph nodes in BC patients with LumA or Lob who are candidates to primary surgery.

    Time frame: Day 50

06

Study locations

1 of 1 sites recruiting
  • IRCCS Ospedale San Raffaele
    Milan, MI 20132, Italy
    Recruiting
07

References and documents

Publications

  • Franquet E, Park H. Molecular imaging in oncology: Common PET/CT radiopharmaceuticals and applications. Eur J Radiol Open. 2022 Nov 24;9:100455. doi: 10.1016/j.ejro.2022.100455. eCollection 2022. PubMed 36439301 ↗
  • Schumacher K, Inciardi M, O'Neil M, Wagner JL, Shah I, Amin AL, Balanoff CR, Larson KE. Is axillary imaging for invasive lobular carcinoma accurate in determining clinical node staging? Breast Cancer Res Treat. 2021 Feb;185(3):567-572. doi: 10.1007/s10549-020-06047-w. Epub 2021 Jan 3. PubMed 33389408 ↗
  • Iorfida M, Maiorano E, Orvieto E, Maisonneuve P, Bottiglieri L, Rotmensz N, Montagna E, Dellapasqua S, Veronesi P, Galimberti V, Luini A, Goldhirsch A, Colleoni M, Viale G. Invasive lobular breast cancer: subtypes and outcome. Breast Cancer Res Treat. 2012 Jun;133(2):713-23. doi: 10.1007/s10549-012-2002-z. Epub 2012 Mar 8. PubMed 22399188 ↗
08

Registry details

Key details

Study ID
NCT05982496
Lead sponsor
Università Vita-Salute San Raffaele
Collaborators
IRCCS San Raffaele
Responsible party
Rosa Di Micco, MD (Principal Investigator, IRCCS San Raffaele) — Principal investigator
First posted
Aug 8, 2023
Start date
Jun 9, 2026
Primary completion
Jun 15, 2029 (estimated)
Completion
Dec 1, 2029 (estimated)
Last update
Jun 12, 2026

Study contacts

Rosa Di Micco, MD
Contact
dimicco.rosa@hsr.it
+39022643 ext. 4565
Nicole Rotmensz, MSc
Contact
rotmensz.nicole@hsr.it
+39022643 ext. 5650

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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