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18F FES-PET/MRI for Tailoring Treatment of Luminal a and Lobular Breast Cancer
Sponsor: Università Vita-Salute San Raffaele
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.
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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
221
Start Date
2025-03-01
Completion Date
2028-11-01
Last Updated
2024-12-10
Healthy Volunteers
No
Conditions
Interventions
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.
PET/MRI B
Two additional PET/MRI will be performed before and after induction ET.
PET/MRI C
Two additional PET/MRI will be performed before and after two cycles of neoadjuvant chemotherapy.
PET/MRI D
Two additional PET/MRI will be performed before and after two cycles of systemic therapy.
Translational analysis
Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.