Cone Beam Computed Tomography for Breast Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 401
- 试验地点
- 1
- 主要终点
- Concordance and discordance of CBCT imaging with diagnostic mammography, other breast-imaging modalities, and histopathology
研究概览
简要总结
The primary aim of this study is to continue the investigation of cone beam computed tomography (CBCT) for breast imaging already underway in the diagnostic setting by providing a compelling body of evidence incorporating non-contrast CBCT in the study protocol. The goal is to accumulate a body of evidence to provide data to incorporate CBCT into the diagnostic work-up of breast lesions.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females at least 35 years of age of any ethnicity
- •Had a mammogram, read as BI-RADS® 1 or 2
- •Will undergo study imaging no later than four weeks from date of mammogram.
- •Is able to undergo informed consent.
- •Females at least 35 years of age of any ethnicity
- •Require diagnostic imaging
- •Will undergo study imaging no later than four weeks from date of diagnostic mammogram
- •Is able to undergo informed consent
排除标准
- •Group I and Group II:
- •Pregnancy
- •Lactation
- •Subjects with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker.
- •Subjects who are unable to tolerate study constraints.
- •Subjects who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to)
- •Treatment for enlarged thymus gland as an infant
- •Irradiation for benign breast conditions, including breast inflammation after giving birth
- •Treatment for Hodgkins disease
- •Subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
- •Subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)
- •Tuberculosis
- •Severe scoliosis
结局指标
主要结局
Concordance and discordance of CBCT imaging with diagnostic mammography, other breast-imaging modalities, and histopathology
时间窗: about 3 years
The primary measure of this study will include the following aspects. * the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam * patient's comfort during the CBCT exam vs the mammographic exam * the concordance and discordance of CBCT breast imaging with standard mammography and other breast-imaging studies * the concordance and discordance of CBCT breast imaging with histopathology * number of participants with adverse events as a measure of safety
次要结局
未报告次要终点