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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Sensitivity of FES PET/MRI in detecting macrometastatic axillary lymph nodes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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%
排除标准
- •ER-negative tumors
- •Pregnancy;
- •Contraindication to PET;
- •Contraindication to MRI;
- •Claustrophobia;
- •Allergy to the MR contrast agent;
- •Severe renal insufficiency
研究组 & 干预措施
Cohort A
- Candidates to surgery as first treatment regardless of cN
- ER+ Her2 negative BC with ki67>10%
干预措施: PET/MRI A (Procedure)
Cohort A
- Candidates to surgery as first treatment regardless of cN
- ER+ Her2 negative BC with ki67>10%
干预措施: FES (Drug)
Cohort A
- Candidates to surgery as first treatment regardless of cN
- ER+ Her2 negative BC with ki67>10%
干预措施: Translational analysis (Genetic)
结局指标
主要结局
Sensitivity of FES PET/MRI in detecting macrometastatic axillary lymph nodes
时间窗: 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.
次要结局
- Changes in Standard Uptake Value (SUV) of FES in patients undergoing induction Endocrine Treatment (ET)(Day 0 and Day 50)
研究者
Rosa Di Micco, MD
Principal Investigator
IRCCS San Raffaele