Contrast Enhanced Ultrasound and Shear Wave Elastography in Measuring Response in Patients With Breast Cancer Receiving Chemotherapy Before Surgery
Real Time Contrast Enhanced Ultrasound and Ultrasound-Based Elastography: Novel Techniques in Assessment of Treatment Response to Neoadjuvant Chemotherapy for Breast Cancer
研究概览
地位
条件
详细说明
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).
SECONDARY OBJECTIVES:
I. To explore the role of combined CEUS + SWE features obtained at early treatment phase (2-3 weeks following initiation of NAC), in accurately predicting the pathologically determined tumor response.
II. To investigate the agreement in assessment of therapy response to NAC between CEUS versus contrast enhanced magnetic resonance imaging (CE MRI) and SWE versus CE MRI for baseline versus pre-surgery scan and to identify discordant cases using scatter plot and contingency tables.
OUTLINE:
Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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California
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Los Angeles、California、美国、90033
- USC Norris Comprehensive Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的: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.
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Undergo CEUS
其他名称:
Undergo SWE
其他名称:
Participant will receive contrast agent by intravenous administration
其他名称:
Equipment used for SWE
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Model predicted treatment response for CEUS and SWE
大体时间:Up to 1 year
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Weighted Kappa will be used to assess the agreement.
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Up to 1 year
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Pathologically determined treatment response for CEUS and SWE
大体时间:Up to 1 year
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Weighted Kappa will be used to assess the agreement.
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Up to 1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Treatment response predicted by novel ultrasound techniques
大体时间:Up to 1 year
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Weighted Kappa will be used to assess the agreement.
Scatter plots and contingency tables will be used to identify discordant cases between US techniques and CE MRI.
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Up to 1 year
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Treatment response predicted by CE MRI
大体时间:Up to 1 year
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Weighted Kappa will be used to assess the agreement.
Scatter plots and contingency tables will be used to identify discordant cases between US techniques and CE MRI.
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Up to 1 year
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合作者和调查者
调查人员
- 首席研究员:Linda Hovanessian-Larsen、University of Southern California
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
dynamic contrast-enhanced ultrasound imaging的临床试验
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Sidney Kimmel Cancer Center at Thomas Jefferson...National Cancer Institute (NCI); University of California, San Diego; GE Healthcare; National Institutes... 和其他合作者完全的