Evaluation of Contrast-enhanced Mammography and Contrast-enhanced Breast Tomosynthesis: Comparison to Contrast-enhanced Breast MRI- A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- A PILOT study to determine Cancer lesion enhancement with CEM and CEBT is non-inferior to that of CEMRI.
研究概览
简要总结
This is a pilot study to evaluate 2D contrast-enhanced mammography image and 3D (tomosynthesis) contrast-enhanced images to contrast enhanced MRI in women with greater than 95% probability of breast cancer (BIRADS 5) or confirmed breast cancer (BIRADS 6).This study will then be used to design additional studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is a female of any race and ethnicity.
- •Subject is at least 25 years old
- •Subject has or will have a contrast enhanced breast MRI +/- 31 days of enrollment with no interval treatment or procedure between the two studies
- •Subject has BIRADS 6 or BIRADS 5 cancer or as determined by the radiologist
- •>50% of the biopsied cancer mass must remain following biopsy OR
- •A calcification must be at least 2cm in maximum dimension prior to biopsy or at least 1cm in maximum dimension following biopsy
排除标准
- •Subject is unable or unwilling to undergo informed consent
- •Subject has breast implant in the breast to be imaged
- •Subject is pregnant
- •Subject is breast feeding or lactating
- •Subject has a known allergy to gadolinium contrast agents.
- •Subject has a contraindication for MRI.
- •Subject suspected to be at risk to complication from the contrast agents.
- •Subject has a documented renal insufficiency,
- •Subject requires renal dialysis.
- •Subject has had a prior reaction to iodinated contrast.
- •Subject has had a prior episode of anaphylactic reaction to any substance.
- •Subject has taken metformin (Glucophage) within 48 hours of study procedures.
- •Subject has multiple allergies and/or severe asthma regularly treated with medication (prescription and/or over-the-counter).
结局指标
主要结局
A PILOT study to determine Cancer lesion enhancement with CEM and CEBT is non-inferior to that of CEMRI.
时间窗: Fall 2012
This Pilot study is designed to evaluate two x-ray contrast methods with contrast enhanced MRI. Each subject will be imaged with CEM, CEBT and CEMRI. The goals for this will be to: i) Using a Likert scale, Compare the enhancement of breast cancer lesions with CEM, CEBT and CEMRI. ii) Using a Likert scale, Compare the enhancement of benign breast lesions with CEM, CEBT and CEMRI. The results of this study will be used to design studies to measure the sensitivity and specificity of CEM and CEBT.
次要结局
- Comparison of lesion conspicuity(up to one year post study enrollment)