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Recruiting
NCT05982496
18F FES-PET/MRI for Tailoring Treatment of Luminal A and Lobular Breast Cancer
Conditions: Breast Cancer Female, Lobular Breast Carcinoma, PET/MRI, Axillary Lymphadenopathy, Luminal A Breast Cancer
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 119
Sponsor: Università Vita-Salute San Raffaele
Location: IRCCS Ospedale San Raffaele Milan MI
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 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
Source: ClinicalTrials.gov (NCT05982496). StuddyBuddy aggregates publicly available trial information.
