RecruitingPhase 2NCT05982496

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


Sponsor

Università Vita-Salute San Raffaele

Enrollment

119 participants

Start Date

Jun 9, 2026

Study Type

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called FES, a procedure called PET/MRI A, and others for people with axillary lymphadenopathy, breast cancer female, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFES

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

PROCEDUREPET/MRI A

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

GENETICTranslational analysis

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


Locations(1)

IRCCS Ospedale San Raffaele

Milan, MI, Italy

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NCT05982496


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