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

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

Recruiting
18 years and older
Female
Phase 2

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Overview

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.

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.

Eligibility

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:

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

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

NCT05982496

Università Vita-Salute San Raffaele

27 June 2026

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