About this trial
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
This trial does not accept healthy volunteersQualifiers
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%
Disqualifiers
ER-negative tumors
Pregnancy;
Contraindication to PET;
Contraindication to MRI;
Trial design
Single group
Treatments tested in this trial
FES
Drug16-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
Procedure/SurgeryAn additional FES PET/MRI will be performed before surgery.
Translational analysis
GeneticSelected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.
Treatment groups
Trial outcomes
Primary outcomes
Sensitivity of FES PET/MRI in detecting macrometastatic axillary lymph nodes
Ability of FES PET/MRI to detect macrometastatic (tumor deposit\>2mm) axillary lymph nodes in BC patients with LumA or Lob who are candidates to primary surgery.
Sponsors and contacts
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Università Vita-Salute San Raffaele
Lead sponsor
IRCCS San Raffaele
Sponsor institution
IRCCS San Raffaele
Collaborator