NCT01090687已完成不适用
Role of 3D Tomography in Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Correlation between mammography and breast CT on lesion detection
研究概览
简要总结
The primary aim of this pilot study is to define the role of dedicated cone beam breast computed tomography in breast cancer imaging. This research is a prelude of a more comprehensive clinical trial that may follow.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women, age 40 or older, who are scheduled for biopsy after classification as BI-RADS 4/5 and have had a screening or diagnostic full-field digital mammography (FFDM) exam are eligible to participate, except for exclusions noted below.
- •Able to provide informed consent.
排除标准
- •Women less than 40 years old
- •Pregnant women
- •Lactating women
- •Woman who have had bilateral mastectomies
- •Women 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
- •Women who are unable to tolerate study constraints, frail or unable to cooperate
- •Women with large breasts that cannot be accommodated within the field of view of the CT system
- •Women 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 Hodgkin's disease
- •Women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
- •Women 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
Correlation between mammography and breast CT on lesion detection
时间窗: 2 years
There are two specific aims of this pilot study. One specific aim is to determine if the lesions that are detected by mammography and referred for biopsy, are visible with breast CT. The other specific aim is to determine if there is a correlation between CT numbers and malignancy, in particular for soft tissue (solid masses) abnormalities and to determine if image processing techniques improve correlation between CT numbers and malignancy.
次要结局
未报告次要终点
研究者
研究点 (1)
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