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
Overview
- Phase
- Not Applicable
- Intervention
- PET/MRI A
- Conditions
- Breast Cancer Female
- Sponsor
- Università Vita-Salute San Raffaele
- Enrollment
- 221
- Primary Endpoint
- Sensitivity of FES PET/MRI in detecting macrometastatic axillary lymph nodes
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
Rosa Di Micco, MD
Principal Investigator
IRCCS San Raffaele
Eligibility Criteria
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
Arms & Interventions
Cohort A
* Candidates to surgery as first treatment regardless of cN * ER+ Her2 negative BC with ki67\>10%
Intervention: PET/MRI A
Cohort A
* Candidates to surgery as first treatment regardless of cN * ER+ Her2 negative BC with ki67\>10%
Intervention: FES
Cohort A
* Candidates to surgery as first treatment regardless of cN * ER+ Her2 negative BC with ki67\>10%
Intervention: Translational analysis
Cohort B
• ER positive BC treated with induction ET
Intervention: FES
Cohort B
• ER positive BC treated with induction ET
Intervention: PET/MRI B
Cohort B
• ER positive BC treated with induction ET
Intervention: Translational analysis
Cohort C
• Candidates to neoadjuvant chemotherapy
Intervention: FES
Cohort C
• Candidates to neoadjuvant chemotherapy
Intervention: PET/MRI C
Cohort C
• Candidates to neoadjuvant chemotherapy
Intervention: Translational analysis
Cohort D
• Metastatic LumA or ER-positive Lob BC, at first diagnosis or in progression
Intervention: FES
Cohort D
• Metastatic LumA or ER-positive Lob BC, at first diagnosis or in progression
Intervention: PET/MRI D
Cohort D
• Metastatic LumA or ER-positive Lob BC, at first diagnosis or in progression
Intervention: Translational analysis
Outcomes
Primary Outcomes
Sensitivity of FES PET/MRI in detecting macrometastatic axillary lymph nodes
Time Frame: 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 Outcomes
- Changes in Standard Uptake Value (SUV) of FES in patients undergoing induction Endocrine Treatment (ET)(Day 0 and Day 50)