Real Time Contrast Enhanced Ultrasound and Ultrasound-Based Elastography: Novel Techniques in Assessment of Treatment Response to Neoadjuvant Chemotherapy for Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Model predicted treatment response for CEUS and SWE
研究概览
简要总结
This pilot clinical trial studies contrast enhanced ultrasound and shear wave elastography in measuring response in patients with breast cancer receiving chemotherapy before surgery. New imaging procedures, such as contrast enhanced ultrasound and shear wave elastography, may predict treatment response earlier and more accurately than contrast enhanced magnetic resonance imaging.
详细描述
PRIMARY OBJECTIVES:
I. To establish a quantitative prediction rule for accurate and early prediction of the pathologic tumor response assessed post-surgery, using the change of contrast enhanced ultrasound (CEUS) assessed tumor size and perfusion characteristics before (baseline) and 2-3 weeks following initiation of neoadjuvant chemotherapy (NAC).
II. To assess the agreement between CEUS based classification rule and pathologically determined treatment response (baseline versus pre-surgical scan).
III. To establish a quantitative prediction rule for accurate and early prediction of the pathologic tumor response assessed post-surgery, using the change in propagation velocity of a shear mechanical wave in tissue before (baseline) and 2-3 weeks following initiation of NAC.
IV. To assess the agreement between shear wave elastography (SWE) based classification rule and pathologically determined treatment response (baseline versus pre-surgical scan).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with histologically confirmed breast cancer (by core needle biopsy)
- •Women with >= 2 cm clinically or radiologically measureable breast cancer
- •Women scheduled to receive neoadjuvant chemotherapy as part of their treatment plan
- •Women competent to sign study specific written Informed Consent
- •Women willing to comply with protocol requirements
排除标准
- •Women who are pregnant
- •Women who have undergone open surgical (excisional) biopsy for breast cancer diagnosis
- •Women who have had a prior history of breast cancer in the same breast
- •Women with known cardiac shunt, pulmonary hypertension or hypersensitivity to perflutren agent
- •Women who cannot consent for themselves
研究组 & 干预措施
Diagnostic (CEUS, SWE)
Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery.
干预措施: dynamic contrast-enhanced ultrasound imaging (Procedure)
Diagnostic (CEUS, SWE)
Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery.
干预措施: shear wave elastography (Procedure)
Diagnostic (CEUS, SWE)
Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery.
干预措施: Definity, (Lipid Microspheres) Intravenous Suspension (Drug)
Diagnostic (CEUS, SWE)
Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery.
干预措施: Philips Shear Wave Elastography (Device)
结局指标
主要结局
Model predicted treatment response for CEUS and SWE
时间窗: Up to 1 year
Weighted Kappa will be used to assess the agreement.
Pathologically determined treatment response for CEUS and SWE
时间窗: Up to 1 year
Weighted Kappa will be used to assess the agreement.
次要结局
- Treatment response predicted by novel ultrasound techniques(Up to 1 year)
- Treatment response predicted by CE MRI(Up to 1 year)