NCT01880580已完成不适用
Cone Beam CT for Breast Imaging: A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Image Quality of Cone Beam Breast CT
研究概览
简要总结
The objective of this pilot study is to investigate Cone Beam Computed Tomography Imaging (CBCT), with the primary goal, the accumulation of a body of evidence to provide preliminary data for a future extensive clinical trials.
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
- 是
入选标准
- •Are at least 40 years of age of any ethnicity
- •Had a routine mammogram, read as BI-RADS® 0, 1, 2 or 3
- •Will undergo study imaging no later than six months from date of routine mammogram.
- •Is able to undergo informed consent.
排除标准
- •Pregnancy
- •Lactation
- •Patients 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.
- •Patients who are unable to tolerate study constraints.
- •Patients 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
- •Patients who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
- •Patients who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)
- •Tuberculosis
- •Severe scoliosis
- •Diagnostic Group:
- •Inclusion Criteria:
- •Women who are at least 40 years of age of any ethnicity
- •Have a palpable abnormality detected by Breast Self Exam (BSE), or Clinical Breast Exam (CBE) or have a non-palpable abnormality detected by an imaging modality
- •After diagnostic work-up are categorized as BI-RADS® 4 or
- •Are scheduled for biopsy either by large gauge needle biopsy or excisional biopsy.
- •Will undergo study imaging prior to biopsy and within four weeks of diagnostic work-up.
- •Exclusion Criteria:
- •Pregnancy
- •Lactation
- •Patients who have already undergone biopsy for the index lesion
- •Patients who are unable or unwilling to undergo biopsy for the lesion of concern
- •Patients with physical limitations that may prohibit the patient from resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker.
- •Patients who are unable to tolerate study constraints.
- •Patients who have received radiation treatments to the thorax or breast area 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
- •Patients who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
- •Patients 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
Image Quality of Cone Beam Breast CT
时间窗: 6 years
This study was to evaluate the radiation dose, breast coverage, and image quality of cone-beam breast CT compared with a conventional mammographic examination.
次要结局
未报告次要终点
研究者
研究点 (1)
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