Cone Beam Breast CT for Breast Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,024
- 试验地点
- 4
- 主要终点
- Recall Rates
研究概览
简要总结
Up to one thousand and twenty-eight (1028) patients from screening and diagnostic population will be enrolled and consented to participate in the study to create an enriched data set. These women will be enrolled from annual screening population and diagnostic workup population. The enrolled patient will undergo KBCT scans within 4 weeks of her screening or diagnostic mammography exam and before breast biopsy occurs if biopsy is needed.
详细描述
Up to one thousand and twenty-eight (1028) patients from screening and diagnostic population will be enrolled and consented to participate in the study to create an enriched data set. These women will be enrolled from annual screening population and diagnostic workup population. The enrolled patient will undergo KBCT scans within 4 weeks of her screening or diagnostic mammography exam and before breast biopsy occurs if biopsy is needed.
Only women will be recruited for this study. Although men can get breast cancer, male breast cancer incidence is low and is not considered to be a great health issue. Thus, this study will exclude males with breast disease.
Women of ages 40 and above will be recruited for participation in the study. There are no enrollment restrictions based on race or ethnic origin. Patients enrolled in the study will have their standard-of-care screening mammography exams performed at the facility. A radiologic technologist, registered in radiography and mammography through the ARRT will perform the Screening Mammography procedure.
For patients enrolled in the study, a bilateral KBCT scan of both breasts (or unilateral scan if the subject has had a mastectomy) will be performed within 4 weeks of the mammography exam.
For all the subjects, the mammograms will be obtained as part of the standard of care and only the 3D KBCT imaging represents additional x-ray exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Screening Group:
- •Female sex of any ethnicity
- •Age 40 years or older
- •Scheduled for a routine screening mammography exam within 4 weeks.
- •Diagnostic Group:
- •Female sex of any ethnicity
- •Age 30 years or older
- •Have an abnormality detected by Breast Self Exam (BSE), or Clinical Breast Exam (CBE), or have an abnormality detected by an imaging modality.
- •Will undergo diagnostic mammography, prior to breast biopsy (if needed).
排除标准
- •Pregnancy
- •Lactation
- •Unknown pregnancy status AND
- •has refused pregnancy testing and
- •has refused to sign a pregnancy test waiver
- •Women who are unable or unwilling to understand or to provide informed consent
- •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.
- •Women 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
- •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 Additional exclusion criteria due to machine limitations
- •Patient's body weight is over the limit of the scanner table (440 lbs. or 200kg)
研究组 & 干预措施
CBBCT Imaging Screening Patients
Patient undergo bilateral CBBCT imaging (or unilateral CBBCT imaging if the patient had mastectomy) within 4 weeks of screening mammography.
干预措施: CBBCT Imaging (Device)
CBBCT Imaging Screening Patients
Patient undergo bilateral CBBCT imaging (or unilateral CBBCT imaging if the patient had mastectomy) within 4 weeks of screening mammography.
干预措施: Digital Mammography (Device)
CBBCT Imaging Diagnostic Patients
Patient undergo bilateral CBBCT imaging (or unilateral CBBCT imaging if the patient had mastectomy) within 4 weeks of diagnostic mammography.
干预措施: CBBCT Imaging (Device)
CBBCT Imaging Diagnostic Patients
Patient undergo bilateral CBBCT imaging (or unilateral CBBCT imaging if the patient had mastectomy) within 4 weeks of diagnostic mammography.
干预措施: Digital Mammography (Device)
结局指标
主要结局
Recall Rates
时间窗: 3 months after CBBCT image review and Mammography image review
The overall recall rates of CBBCT imaging and Mammography imaging
Radiation Dose
时间窗: 3 months after the CBBCT imaging and Mammography imaging
The radiation dose of CBBCT imaging and Mammography imaging
次要结局
未报告次要终点