NCT01750320已完成1 期
Koning Breast CT-guided Biopsy Phase I Trial
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- The accuracy of Koning breast CT-guided biopsy
研究概览
简要总结
The primary aim of this study is to show that the accuracy of Koning Breast CT-guided biopsy is at least equivalent to that of stereotactic-guided biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female at least 35 years of age of any ethnicity
- •Lesion seen on mammography
- •Diagnostic report read as BI-RADS 4 or 5
- •Will undergo biopsy no later than four weeks from date of mammogram
- •Is able to undergo informed consent
排除标准
- •Pregnancy
- •Lactation
- •Subjects with breast implants
- •Subjects with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pacemaker.
- •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
研究组 & 干预措施
Koning Breast CT - guided Biopsy
Experimental
干预措施: Koning Breast CT-guided Biopsy (Device)
结局指标
主要结局
The accuracy of Koning breast CT-guided biopsy
时间窗: about 1 year
The goal of this study is to evaluate the concordance of Koning Breast CT-guided Biopsy (KBCT-GBx) results to diagnostic work-up imaging (at least mammographic) and KBCT imaging and to verify that the localization and guidance accuracy of KBCT-GBx is at least equivalent to stereotactic-guided biopsy to validate the localization and guidance accuracy of KBCT-GBx.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Dedicated Breast CT for Quantitative Breast Density Measurements in Mexican-origin Women in Southern ArizonaMetabolic SyndromeObesity Associated DisorderNCT04799665University of Arizona92
已完成
不适用
Cone Beam CT for Breast ImagingBreast ImagingBreast CancerNCT01880580Koning Corporation76
已完成
1 期
Cone Beam Computed Tomography for Breast ImagingBreast CancerNCT00972413Koning Corporation104
已完成
不适用
Koning Breast Computed Tomography Guided Neoadjuvant Treatment MonitoringBreast CancerNCT01771497Koning Corporation12
进行中（未招募）
不适用
Feasibility and Identification of Breast Cancer Patients for Potential Avoidance of SurgeryBreast CancerNCT02455791M.D. Anderson Cancer Center43