FES-PET/MRI to tailor treatment for Luminal A and ER-positive lobular breast cancer
Official title: 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
Run by Università Vita-Salute San Raffaele · NCT05982496 · Data updated 2026-11-12
This study tests whether a combined FES-PET/MRI scan can help plan treatment for women with Luminal A or ER-positive lobular breast cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 119 (estimated) |
| Sponsor | Università Vita-Salute San Raffaele Academic / other |
| Locations | 1 site (Milan, MI) |
| Status | Recruiting |
| Started | June 9, 2026 |
| Main results expected | June 15, 2029 |
| Study ends | December 1, 2029 |
| Registry record updated | June 12, 2026 |
| Trial ID | NCT05982496 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older with Luminal A or ER-positive lobular breast cancer who are planned for primary surgery.
✕Probably not a fit
Patients with ER-negative tumors, contraindications to PET or MRI, pregnancy, claustrophobia, MR contrast allergy, or severe kidney impairment may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, prospective cohort study enrolling women with Luminal A or ER-positive lobular breast cancer to undergo FES-PET/MRI imaging before primary surgery. The goal is to assess how well FES-PET/MRI can stage axillary disease compared with surgical axillary staging. The study also explores biological factors that contribute to tumor heterogeneity. Interventions include FES, PET/MRI imaging, and translational analyses on collected samples.
Why it matters
Potential benefit: If successful, imaging could guide more accurate staging and potentially personalize surgical and adjuvant treatment decisions.
How similar studies have gone: Previous work with targeted PET tracers like FES shows promise in characterizing ER-positive tumors, but this exact FES-PET/MRI approach for axillary staging is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
IRCCS Ospedale San Raffaele
Milan, Mi, Italy Recruiting
Study contacts
- Study coordinator: Rosa Di Micco, MD
- Email: dimicco.rosa@hsr.it
- Phone: +39022643
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.