Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up Women only

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.

More Breast Cancer Female trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment119 (estimated)
SponsorUniversità Vita-Salute San Raffaele
Academic / other
Locations1 site (Milan, MI)
StatusRecruiting
StartedJune 9, 2026
Main results expectedJune 15, 2029
Study endsDecember 1, 2029
Registry record updatedJune 12, 2026
Trial IDNCT05982496 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.