Clinical Feasibility Study of Upright, Low-dose, High-resolution, 3D Breast CT (UBCT).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Feasibility of UBCT
研究概览
简要总结
The investigators are doing this study to find out if a new kind of breast imaging (called upright dedicated breast CT or UBCT) can help doctors to see the small structures in breast tissue more clearly in 3-D and without overlap.
The breast imaging device that will be used in this study (UBCT) is not FDA-approved, so this is a research study. The machine has been designed to remove mammography-like breast compression and use radiation dose comparable to mammography. The breast CT device will take multiple x-ray pictures of the subjects breast in approximately 20 seconds and create a 3-D image of the breast. It does not compress or squish the breast like a mammogram.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For the screening cohort, the inclusion criteria are, women:
- •(1) who were 40 years of age or older (typical screening age range), and,
- •(2) who were asymptomatic, and,
- •(3) who underwent or scheduled to undergo a standard-of-care 2-view bilateral digital breast tomosynthesis screening exam.
- •For the diagnostic cohort, the inclusion criteria are, women:
- •(1) who were 40 years of age or older, and,
- •(2) who underwent a standard-of-care 2-view bilateral digital breast tomosynthesis exam, and,
- •(3) who were assigned BI-RADS category 4 or 5 after diagnostic work-up and are scheduled for biopsy.
排除标准
- •Women less than 40 years old
- •pregnant or lactating women
- •women with physical limitations (e.g., kyphosis) that may prohibit UBCT exam
- •women who have received radiation treatments to the thorax
- •women who have participated in a prior breast clinical trial that gave additional radiation dose
- •women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as tuberculosis, and severe scoliosis.
研究组 & 干预措施
Screening cohort
Women who undergo breast cancer screening using mammography and/or digital breast tomosynthesis.
干预措施: Low dose, upright, dedicated breast CT (Device)
Diagnostic cohort
Women who have suspicious finding(s) that require biopsy.
干预措施: Low dose, upright, dedicated breast CT (Device)
结局指标
主要结局
Feasibility of UBCT
时间窗: From enrollment to end of study in approximately 6 months.
The proportion of participants who successfully complete the imaging exam using upright, dedicated breast CT (UBCT).
次要结局
未报告次要终点