Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Beta of CT Axial View
研究概览
简要总结
The purpose of this study is to compare the imaging performance of an investigational breast computed tomography (CT) scanner, built at UC Davis, with that of an FDA-Approved breast tomosynthesis scanner (capable of producing standard 2-D mammography and 3-D tomosynthesis images), built by Hologic, Incorporated, in a group of patients with suspected breast cancer.
详细描述
The primary aim of this study is the comparison of Beta values of several different CT and Tomosynthesis views (Beta of CT Sagittal View, Beta of CT Coronal View, Beta of CT Axial View, Beta of Tomosynthesis Craniocaudal View, Beta of Tomosynthesis Medial Lateral Oblique View). Lower Beta values correspond to better image quality (less noise, increased cancer detection).
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
- •35 years of age or older
- •While male patients will not be explicitly excluded, it is expected that all patients in this study will be women
- •Diagnostic findings from prior mammography suspicious for, or highly suggestive of, breast malignancy -BIRADS (Breast Imaging Reporting and Data System) categories 4 and 5
- •Scheduled for ultrasound or stereotactic core biopsy
- •Ability to lie still on a table top for up to 10 minutes, longer than the typical breast CT duration.
- •Ability to understand risks, procedures, and benefits involved
排除标准
- •Recent breast biopsy
- •History of breast augmentation implant
- •Pregnant or Positive urine pregnancy test (UPT) or currently breast-feeding
- •History of moderate or severe adverse reaction to iodinated contrast injection
- •Recent serum creatinine ≥ 1.5 mg/dL
- •History of Diabetes Mellitus
- •Currently taking Glucophage or Glucovance (Metformin)
- •History of chronic asthma
- •History of allergy to iodine
- •Multiple food and/or drug allergy
- •Renal disease
- •History of pulmonary disease, phobia of breath holding, or other condition that could prevent the subject from being able to perform the 16 second breath hold
结局指标
主要结局
Beta of CT Axial View
时间窗: Day 1
frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).
Beta of CT Coronal View
时间窗: Day 1
frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).
Beta of Tomosynthesis Craniocaudal View
时间窗: Day 1
frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).
Beta of CT Sagittal View
时间窗: Day 1
frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).
Beta of Tomosynthesis Medial Lateral Oblique View
时间窗: Day 1
frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af\^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection).
次要结局
未报告次要终点