Breast Cancer Female, Lobular Breast Carcinoma, PET/MRI, Axillary Lymphadenopathy, Luminal a Breast Cancer
Conditions
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 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.
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 chemotherapy; systemic therapy for metastatic disease. For the purpose of the study an additional FES PET/MRI exam will be performed at baseline for local and systemic staging and a second exam after systemic therapy. Correlations between FES PET/MRI parameters and pathology, gene expression and FDG PET parameters, when available, will be investigated. Aim 1: Evaluating the performance of FES PET/MRI in axillary staging compared with axillary surgery. Aim 2: Evaluating potential correlations between changes in FES uptake and changes in proliferation index after 3 weeks of endocrine therapy before surgery. Aim 3: Evaluating the performance of FES PET/MRI in staging of patients undergoing systemic therapy in comparison with standard imaging. Additionally, biological determinants of tumor heterogeneity will be investigated.
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.
PROCEDUREPET/MRI B
Two additional PET/MRI will be performed before and after induction ET.
PROCEDUREPET/MRI C
Two additional PET/MRI will be performed before and after two cycles of neoadjuvant chemotherapy.
PROCEDUREPET/MRI D
Two additional PET/MRI will be performed before and after two cycles of systemic therapy.
GENETICTranslational analysis
Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.
Sponsors
IRCCS San Raffaele
Università Vita-Salute San Raffaele
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Cohort A * candidates to surgery as first treatment regardless of cN * ER+ 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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* ER-negative tumors * Pregnancy; * Contraindication to PET; * Contraindication to MRI; * Claustrophobia; * Allergy to the MR contrast agent; * Severe renal insufficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of FES PET/MRI in detecting macrometastatic axillary lymph nodes | Day 50 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Standard Uptake Value (SUV) of FES in patients undergoing induction Endocrine Treatment (ET) | Day 0 and Day 50 | To investigate the potential correlation between Δ(FES SUV) and Δ(Ki-67 as proliferation index) after induction ET in luminal BC. |
Other
| Measure | Time frame | Description |
|---|---|---|
| FES PET/MRI sensitivity compared to that of standard imaging in patients undergoimg systemic therapy for neoadjuvant purposes or for metastatic disease. | Day 0 | Results from FES PET/MRI will be compared with those from standard imaging in terms of sensitivity and number of lesions detected. |
| FES PET/MRI ability to predict tumor response or no response to therapy | Day 180 | Results of FES PET/MRI after two cycles of therapy will be compared to final pathology (cohort C) or standard imaging at 6 months (cohort D) |
Contacts
Primary ContactRosa Di Micco, MD
Backup ContactNicole Rotmensz, MSc
Outcome results
None listed