Evaluation of Breast CT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Comparison of Pre- and Post- Contrast Breast Computed Tomography With Pre- and Post- Contrast Magnetic Resonance Imaging.
研究概览
简要总结
The investigators have studied the potential of breast computed tomography (bCT) for breast imaging under an NIH-funded Biomedical Research Partnership (BRP) grant (R01 EB002138-10), and 4 breast CT scanners have been developed that have imaged over 600 women to date (under more than one IRB-approved protocol). The BRP grant cannot be renewed, and with this (resubmitted) R01 grant application, the investigators seek to finalize the investigators' research in breast CT - The specific aims have been significantly modified as a result of the first critique, and the investigators now focus on a narrower set of remaining issues.
This version of the protocol will add breast magnetic resonance imaging (MRI) to the experimental procedures.
详细描述
Clinical evaluation: Four hundred women who will be having breast biopsy as part of their standard care (BIRADS 4 and 5) will be recruited to undergo additional imaging prior to biopsy, including (research) pre-and post-contrast enhanced breast CT imaging of both breasts, as well as (standard, FDA approved) contrast enhanced breast MRI. The potential of non-contrast enhanced breast CT will be compared using receiver operating characteristic (ROC) methodology against mammography alone, as well as with mammography + tomosynthesis. The breast CT images (including both pre-and post-contrast images) will be compared using ROC methodology against standard-of-care contrast-enhanced MRI (which includes both non-contrast and contrast images). The results of the clinical trials proposed in this investigation should provide strong evidence in regards to the potential of breast CT for breast cancer screening in the normal risk and high risk populations.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age at least 35 years old
- •Diagnostic findings from prior mammography highly suggestive of breast malignancy (BI- RADS® category 4 or BI-RADS® category 5)
- •Not pregnant or breast-feeding
- •Ability to lie motionless for up to 5 minutes
排除标准
- •Recent breast biopsy
- •History of moderate or severe reaction to contrast agent injection
- •History of Allergy to Iodine
- •History of multiple food and/or drug allergy
- •Currently taking Glucophage or Glucovance (Metformin)
- •History of Chronic Asthma
- •History of Diabetes Mellitus
- •Renal (kidney) disease, or solitary kidney
- •Recent lab tests showing elevated serum creatinine (≥ 1.5 mg/dL)
- •Recent lab tests showing estimated glomerular filtration rate (eGFR) ≤ 60 ml/minute
- •Positive urine pregnancy test or currently breast-feeding
- •Inability to understand the risks and benefits of the study
- •The standard MRI contraindications apply, including but not limited to: having a pacemaker or other implanted electronic device, metal foreign bodies within the eye, aneurysm clips, heart valve prosthesis, vascular stents, coils, intrauterine devices (IUDs), inferior vena cava (IVC) filters, gunshot wounds with retained bullet fragments.
结局指标
主要结局
Comparison of Pre- and Post- Contrast Breast Computed Tomography With Pre- and Post- Contrast Magnetic Resonance Imaging.
时间窗: 5 years
The specific quantitative endpoint of the analysis is the difference in area under the receiver operating characteristic curve (AUC) between contrast-enhanced breast CT (CE-bCT) and contrast-enhanced breast MRI (CE-bMRI).
次要结局
未报告次要终点