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
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.
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.
69 studies on the registry are indexed under Carcinoma, Lobular; 18 are open to participants now.
This study's planned enrollment of 119 is above the median of 59 across 49 interventional studies indexed under Carcinoma, Lobular.
Browse Carcinoma, Lobular studies →Università Vita-Salute San Raffaele is the lead sponsor of 85 studies on the registry; 33 are open to participants now.
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LumA or ER-positive Lobular subtypes
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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* 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
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
An additional FES PET/MRI will be performed before surgery.
Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.
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
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Studies of the drug tested here: Fluoroestradiol f-18
Università Vita-Salute San Raffaele