Interstitial Fluid Pressure Estimation in Breast Cancer Using 3D Subharmonic Signals From Contrast-Enhanced Ultrasound
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Correlation between subharmonic aided pressure estimation (SHAPE) results and direct measurements of interstitial fluid pressure (IFP)
研究概览
简要总结
This clinical trial studies the use of contrast-enhanced ultrasound (CEUS) in estimating tissue pressure in patients with breast cancer. Diagnostic procedures, such as CEUS, may help estimate tissue pressure noninvasively.
详细描述
PRIMARY OBJECTIVE:
I. To determine if the 3-dimensional (3D) subharmonic aided pressure estimation (SHAPE) results can be used to estimate interstitial fluid pressures (IFPs) in breast tumor and its surrounding tissue.
SECONDARY OBJECTIVE:
I. To determine if the malignancy of breast tumor can be predicted by the 3D SHAPE results.
OUTLINE:
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provide signed and dated informed consent form
- •Be conscious, willing and able to comply with all study procedures and be available for the duration of the study
- •At least 21 years old
- •Be scheduled for a breast biopsy (Breast Imaging Reporting and Data System [BIRAD] 4, 4A, 4B, 4C or 5)
- •Patient with an at least 1 cm mass located at < 3 cm depth, approachable by 2.5 inch needle
- •Be medically stable as determined by the investigator
- •If a female of child-bearing potential, must have a negative urine pregnancy test within 24 hours prior to administration of Definity
排除标准
- •Females who are pregnant or nursing
- •Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
- •Patients on life support or in a critical care unit
- •Patients with unstable occlusive disease (e.g., crescendo angina)
- •Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
- •Patients with uncontrolled congestive heart failure (New York Heart Association [NYHA] class IV)
- •Patients with recent cerebral hemorrhage
- •Patients who have undergone surgery within 24 hours prior to the study sonographic examination
- •Patients with known hypersensitivity or allergy to any component of Definity
- •Patients with unstable cardiopulmonary conditions or respiratory distress syndrome
- •Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli
研究组 & 干预措施
Diagnostic (CEUS)
Patients undergo ultrasound without contrast. Patients then receive Definity IV over 15 minutes and undergo CEUS.
干预措施: Ultrasonsgraphy (Procedure)
Diagnostic (CEUS)
Patients undergo ultrasound without contrast. Patients then receive Definity IV over 15 minutes and undergo CEUS.
干预措施: Perflutren Lipid Microcpheres (Drug)
Diagnostic (CEUS)
Patients undergo ultrasound without contrast. Patients then receive Definity IV over 15 minutes and undergo CEUS.
干预措施: Contrast - Enhanced Ultrasound (Procedure)
结局指标
主要结局
Correlation between subharmonic aided pressure estimation (SHAPE) results and direct measurements of interstitial fluid pressure (IFP)
时间窗: At baseline
Pearson's correlation coefficients will be computed between SHAPE results and direct IFP measurements by Stryker compartment pressure monitoring system. A Pearson's correlation coefficient above 0.5 will be considered a successful outcome.
次要结局
- Prediction of malignancy of breast tumor by the 3-dimensional subharmonic aided pressure estimation results(At baseline)