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
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 119
- Locations
- 1
- Primary Endpoint
- Sensitivity of FES PET/MRI in detecting macrometastatic axillary lymph nodes
Study 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 1 cohort undergoing: primary surgery; . Aim : Evaluating the performance of FES PET/MRI in axillary staging compared with axillary surgery. Additionally, biological determinants of tumor heterogeneity will be investigated.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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%
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 (Procedure)
Cohort A
- Candidates to surgery as first treatment regardless of cN
- ER+ Her2 negative BC with ki67>10%
Intervention: FES (Drug)
Cohort A
- Candidates to surgery as first treatment regardless of cN
- ER+ Her2 negative BC with ki67>10%
Intervention: Translational analysis (Genetic)
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)
Investigators
Rosa Di Micco, MD
Principal Investigator
IRCCS San Raffaele