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Contrast Enhanced Ultrasound and Shear Wave Elastography in Measuring Response in Patients With Breast Cancer Receiving Chemotherapy Before Surgery

2019年1月23日 更新者:University of Southern California

Real Time Contrast Enhanced Ultrasound and Ultrasound-Based Elastography: Novel Techniques in Assessment of Treatment Response to Neoadjuvant Chemotherapy for Breast Cancer

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.

研究概览

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

介入性

注册 (实际的)

34

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • Los Angeles、California、美国、90033
        • USC Norris Comprehensive Cancer Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

女性

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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.
Undergo CEUS
其他名称:
  • DCE-USI
Undergo SWE
其他名称:
  • SWE
Participant will receive contrast agent by intravenous administration
其他名称:
  • Perflutren 脂质微球
Equipment used for SWE
其他名称:
  • 剪切波弹性成像

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
Model predicted treatment response for CEUS and SWE
大体时间:Up to 1 year
Weighted Kappa will be used to assess the agreement.
Up to 1 year
Pathologically determined treatment response for CEUS and SWE
大体时间:Up to 1 year
Weighted Kappa will be used to assess the agreement.
Up to 1 year

次要结果测量

结果测量
措施说明
大体时间
Treatment response predicted by novel ultrasound techniques
大体时间:Up to 1 year
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.
Up to 1 year
Treatment response predicted by CE MRI
大体时间:Up to 1 year
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.
Up to 1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Linda Hovanessian-Larsen、University of Southern California

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2013年12月19日

初级完成 (实际的)

2016年9月25日

研究完成 (实际的)

2016年9月25日

研究注册日期

首次提交

2014年2月4日

首先提交符合 QC 标准的

2014年2月18日

首次发布 (估计)

2014年2月20日

研究记录更新

最后更新发布 (实际的)

2019年1月25日

上次提交的符合 QC 标准的更新

2019年1月23日

最后验证

2019年1月1日

更多信息

与本研究相关的术语

其他研究编号

  • 1B-13-8 (其他标识符:USC Norris Comprehensive Cancer Center)
  • P30CA014089 (美国 NIH 拨款/合同)
  • NCI-2014-00085 (注册表标识符:CTRP (Clinical Trial Reporting Program))

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

是的

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

  • Oregon Health and Science University
    未知
    外周动脉疾病
    美国
  • 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
    肝细胞癌 | 化疗栓塞,治疗
    美国
3
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