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使用 3D 次谐波辅助压力估计监测乳腺癌的新辅助化疗

2026年9月18日 更新者:Kibo Nam

This phase II/III trial studies if contrast-enhanced ultrasounds using a contrast dye, perflutren lipid microspheres (Definity), can predict the response to chemotherapy by estimating the pressure in the cancer in patients with breast cancer that has spread to nearby tissues and lymph nodes (locally advanced). The efficacy of cancer therapy is affected by the pressure in the cancer. Definity is a contrast dye used to create better images during ultrasounds. The purpose of this trial is to determine if a special kind of ultrasound, called contrast-enhanced ultrasound, an experimental imaging test, can detect pressures in cancer to determine the response to neoadjuvant chemotherapy in patients with breast cancer.

研究概览

详细说明

PRIMARY OBJECTIVE:

I. To apply and evaluate a novel biomarker from 3-dimensional subharmonic aided pressure estimation (3D SHAPE) to predict neoadjuvant chemotherapy (NAC) response in patients with breast cancer.

SECONDARY OBJECTIVE:

I. To assess whether the accuracy of 3D SHAPE for predicting locally advanced breast cancer (LABC) NAC response varies with breast cancer subtype.

OUTLINE:

Patients undergo contrast-enhanced ultrasound (CEUS) and receive perflutren lipid microspheres intravenously (IV) over 10-15 minutes before NAC, after 10% of NAC, and after 30% of NAC. Patients also undergo unenhanced baseline ultrasound imaging before NAC, after 10% of NAC, after 30% of NAC, and after 100% of NAC.

After completion of study, patients are followed up at the completion of NAC.

研究类型

介入性

注册 (实际的)

122

阶段

  • 阶段2
  • 第三阶段

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

    • Minnesota
      • Rochester、Minnesota、美国、55905
        • Mayo Clinic
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19107
        • Thomas Jefferson University Hospital
    • Texas
      • Dallas、Texas、美国、75390
        • UT Southwestern/Simmons Cancer Center-Dallas

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

21年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Provide signed and dated informed consent form
  • Willing to comply with all study procedures and be available for the duration of the study
  • At least 21 years old
  • Be diagnosed with breast cancer (T1 or greater LABC, any N and M0)
  • Be scheduled for neoadjuvant chemotherapy
  • Be medically stable
  • Be conscious and able to comply with study procedures
  • If a female of child-bearing potential, must have a negative urine pregnancy test

Exclusion Criteria:

  • Males

  • Females who are pregnant or nursing

  • Patients with other primary cancers requiring systemic treatment

  • Patients with any distal metastatic disease

  • Patients undergoing neoadjuvant endocrine therapy

  • 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

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, Definity)

Patients undergo CEUS and receive perflutren lipid microspheres IV over 10-15 minutes before NAC, after 10% of NAC, and after 30% of NAC. Patients also undergo unenhanced baseline ultrasound imaging before NAC, after 10% of NAC, after 30% of NAC, and after 100% of NAC

Undergo CEUS

其他名称:
  • 超声造影

Given IV

其他名称:
  • 确定性

Undergo unenhanced baseline ultrasound

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
Calculation of tumor volume changes with neoadjuvant chemotherapy (NAC)
大体时间:Up to study completion (48 months)

3-dimensional (3D) tumor measurements over the three ultrasound exams will be recorded for each subject to calculate tumor volume changes with NAC. The tumor volume change during the therapy will be compared to imaging (magnetic resonance imaging or ultrasound) and pathologic response as well as to the corresponding 3D subharmonic aided pressure estimation (SHAPE) results.

Up to study completion (48 months)
Prediction of the patients' clinical and pathological response
大体时间:Up to study completion (48 months)

The SHAPE results from three time points (i.e. before, 10% completion, and 30% completion of NAC) will be modeled for predicting the patients' clinical response as well as pathological response using longitudinal logistic regression with adjustment for correlated observations over time by generalized linear mixed effects or generalized estimating equations (GEE) modeling.

Up to study completion (48 months)
The ability of the SHAPE method to distinguish responders from non-responders
大体时间:Up to study completion (48 months)

Will also be compared using receiver operating characteristic analysis to develop thresholds for decision-making based on balancing sensitivity and specificity.

Up to study completion (48 months)

次要结果测量

结果测量
措施说明
大体时间
Accuracy of the 3D SHAPE for predicting locally advanced breast cancer NAC response varies with breast cancer subtype
大体时间:Up to study completion (48 months)

The variation of the accuracies of the SHAPE results by breast cancer subtypes will be reported. The generalized linear mixed effects or GEE modeling will be stratified by breast cancer subtype and also extended to include modeling of breast cancer subtype as a main effect and as an interaction effect with SHAPE.

Up to study completion (48 months)

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。

赞助

调查人员

  • 首席研究员:Kibo Nam, MD、Thomas Jefferson University

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)

2021年4月19日

初级完成 (估计的)

2026年10月31日

研究完成 (估计的)

2026年10月31日

研究注册日期

首次提交

2021年1月14日

首先提交符合 QC 标准的

2021年1月19日

首次发布 (实际的)

2021年1月20日

研究记录更新

最后更新发布 (实际的)

2026年9月23日

上次提交的符合 QC 标准的更新

2026年9月18日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 20F.259
  • R37CA234428 (美国 NIH 拨款/合同)
  • JT 14825 (其他标识符:JeffTrial Number)

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

不

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