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: a Phase II Prospective Cohort Study Evaluating the Performance of FES PET/MRI in Axillary Staging Compared With Axillary Surgery
Università Vita-Salute San Raffaele
119 participants
Jun 9, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria7
- ER-negative tumors
- Pregnancy;
- Contraindication to PET;
- Contraindication to MRI;
- Claustrophobia;
- Allergy to the MR contrast agent;
- Severe renal insufficiency
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05982496