Status:
NOT_YET_RECRUITING
18F FES-PET/MRI for Tailoring Treatment of Luminal a and Lobular Breast Cancer
Lead Sponsor:
Università Vita-Salute San Raffaele
Collaborating Sponsors:
IRCCS San Raffaele
Conditions:
Breast Cancer Female
Lobular Breast Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 funct...
Detailed Description
This is a single-centre prospective cohort study where patients with LumA and ER-positive Lob will be enrolled in 4 cohorts undergoing: primary surgery; induction endocrine therapy; neoadjuvant chemot...
Eligibility Criteria
Inclusion
- Female patients, age\>= 18 yrs, diagnosed with primary or advanced breast cancer
- LumA or ER-positive Lobular subtypes Cohort A
- candidates to surgery as first treatment regardless of cN
- ER-positive Her2 negative BC with ki67\>10% Cohort B
- ER positive BC treated with induction ET Cohort C
- candidates to neoadjuvant chemotherapy Cohort D
- Metastatic LumA or ER-positive Lob BC, at first diagnosis or in progression
Exclusion
- ER-negative tumors
- Pregnancy;
- Contraindication to PET;
- Contraindication to MRI;
- Claustrophobia;
- Allergy to the MR contrast agent;
- Severe renal insufficiency
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT05982496
Start Date
March 1 2025
End Date
November 1 2028
Last Update
December 10 2024
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