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Clinical Trials in Italy / NCT05982496
Recruiting Phase 2

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

NCT05982496 · tracked via the Priya Life Science Italy tracker
Sponsor
Università Vita-Salute San Raffaele
Phase
Phase 2
Started
2026-06-09
Last updated
2026-06-12

Condition(s) studied

Breast Cancer FemaleLobular Breast CarcinomaPET/MRIAxillary LymphadenopathyLuminal A Breast Cancer

Investigational drug(s) / intervention(s)

FESPET/MRI ATranslational analysis

FES: 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

PET/MRI A: An additional FES PET/MRI will be performed before surgery.

Translational analysis: Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.

Study 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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
IRCCS Ospedale San Raffaele Milan MI Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05982496 on ClinicalTrials.gov ↗ ← All trials in Italy