Comparison of Breast Magnetic Resonance Imaging (MRI) and Contrast Enhanced Mammography (CEDM) to Evaluate Residual Disease Extent After Neoadjuvant Therapy (NAT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 5
- 主要终点
- Compare diagnostic accuracy of breast MRI and CEDM
研究概览
简要总结
The purpose of this study is to compare the diagnostic accuracy of breast magnetic resonance imaging (MRI) and contrast enhanced digital mammography (CEDM) in assessing the residual disease extent in patients who have completed neoadjuvant therapy (NAT).
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Any woman who has completed or is nearing completion of neoadjuvant therapy for breast cancer and is scheduled for a post-NAT breast MRI and mammogram
- •Surgery (mastectomy or BCT) planned within 60 days of the MRI
排除标准
- •Women who have a contraindication to the intravenous use of iodinated contrast agent (i.e., allergy to iodinated contrast or severely impaired renal function with a creatinine level > 1.3 or eGFR ≥45)
- •Known allergic reaction to gadolinium; patient may be eligible if the referring physician determines that the MRI is medically necessary and if the patient is willing to undergo pre-medication for contrast allergy
- •Pregnant women
- •Male patients
- •Presence of non MR compatible metallic objects or metallic objects that, in the opinion of the radiologist, would make MRI a contraindication
- •Known or suspected renal impairment. Requirements for GFR prior to MRI as determined by local site standard practice
- •Women who have already had their standard of care post-NAT mammogram and/or breast MRI
研究组 & 干预措施
Breast MRI and Contrast Enhanced Mammography (CEDM)
Breast MRI and CEDM will be performed within 30 days of one another after neoadjuvant therapy
干预措施: Breast Magnetic Resonance Imaging (MRI) (Diagnostic Test)
Breast MRI and Contrast Enhanced Mammography (CEDM)
Breast MRI and CEDM will be performed within 30 days of one another after neoadjuvant therapy
干预措施: Contrast Enhanced Mammography (CEDM) (Diagnostic Test)
结局指标
主要结局
Compare diagnostic accuracy of breast MRI and CEDM
时间窗: 1 year
To compare the diagnostic accuracy of enhancement on MRI and CEDM in evaluating residual disease extent in women who have completed NAT prior to surgical excision
次要结局
未报告次要终点