Assessing the Utility of Tissue Dielectric Constant (TDC) Measurements to Differentiate Breast Cancer From Healthy Breasts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- TDC reference values for breasts
研究概览
简要总结
Patients with pending breast biopsies will have the tumor site's tissue dielectric constant (TDC) measured prior to the biopsy. Similar TDC measurements will be made at a standard breast site on the biopsied breast and on mirrored sites on the non-affected breast.
详细描述
Patients with pending breast biopsies will have the tumor site's tissue dielectric constant (TDC) measured prior to the biopsy. Similar TDC measurements will be made at a standard breast site on the biopsied breast and on mirrored sites on the non-affected breast. Values obtained at the biopsy site will be compared against the outcome of the biopsy analysis: benign vs. malignant. In addition the measurements obtained at the standardized site for all breasts will be used to establish a set of reference values to characterize breast TDC values. In addition, inter-breast differentials will be used to characterize these ranges for future studies and clinical assessments.
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
盲法说明
Measurements are made prior to the biopsy determination of whether tumor is benign or malignant
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •You must be scheduled for a breast biopsy of a breast mass or abnormality with the collaborating centers
排除标准
- •You have any open wounds over the breasts
- •You have had breast cancer
- •You have or have had breast implants or have undergone any breast surgery or breast biopsy
- •You have any implantable wires, this includes a Pacemaker, Implantable Cardioverter ° Defibrillators (ICDs), and/or Left Ventricular Assist Device (LVAD)
- •You are pregnant
研究组 & 干预措施
Biopsied Patients
Patients scheduled for a breast biopsy will have breast tissue dielectric constant measurements made prior to the biopsy
干预措施: TDC differential value (Diagnostic Test)
结局指标
主要结局
TDC reference values for breasts
时间窗: one hour
Composite reference ranges for TDC values as measured on standard breast site of all
TDC Inter-Breast Differentials
时间窗: one hour
Difference between TDC values measured at corresponding sites betweenbreasts
TDC Tumor Differential
时间窗: one hour
Difference between TDC values measured at tumor site between benign vs. malignant
次要结局
未报告次要终点