Diffusion Weighted MR Imaging Biomarkers for Assessment of Breast Cancer Response to Neoadjuvant Treatment: A Sub-study of the I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And MoLecular Analysis)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 406
- 试验地点
- 14
- 主要终点
- Pathologic Complete Response (pCR)
研究概览
简要总结
RATIONALE: Imaging procedures, such as diffusion-weighted magnetic resonance imaging (DWI) and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), may help in evaluating how well patients with breast cancer respond to treatment.
PURPOSE: This research trial studies DWI and DCE-MRI in assessing treatment response in patients with breast cancer undergoing neoadjuvant chemotherapy.
详细描述
OBJECTIVES:
Primary
- To determine if the change in tumor apparent diffusion coefficient (ADC) value measured from each treatment timepoint to baseline is predictive of pathologic complete response (pCR).
Secondary
- To determine if the combined measurement of change in tumor ADC value, change in tumor volume, and change in peak signal-enhancement ratio (SER) is predictive of pCR.
- To investigate the relative effectiveness of the individual measurements, change in tumor ADC value, change in tumor volume, and change in peak SER for predicting pCR in experimental treatment arms.
- To assess the test-retest reproducibility of ADC metrics applied to breast tumors.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Pathologic Complete Response (pCR)
时间窗: Surgery
Pathologic complete response (pCR) is defined as the lack of all signs of cancer in tissue samples removed during surgery after Neoadjuvant treatment for Breast cancer. ie., no residual invasive disease in either breast or axillary lymph nodes after neoadjuvant therapy (ypT0/is, ypN0) Histopathologic analysis was performed using the Residual Cancer Burden system
次要结局
- Within-subject Coefficient of Variation (wCV) Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors(baseline (pre-treatment) or after 3 weeks of taxane-based treatment (early-treatment))
- Repeatability Coefficient (RC)Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors(baseline (pre-treatment) or after 3 weeks of taxane-based treatment (early-treatment))
- Agreement Index (AI) Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors(baseline (pre-treatment) or after 3 weeks of taxane-based treatment (early-treatment))
- Functional Tumor Volume (FTV) as a Predictor of Pathologic Complete Response (pCR)(Surgery)
- ICC Test-retest Metric for Reproducibility of ADC as Applied to Breast Tumors(baseline (pre-treatment) or after 3 weeks of taxane-based treatment (early-treatment))
- Determine the Accuracy of Predictive Models Including Covariates for Combined Measurement of Change in Tumor ADC Value, Change in Tumor Volume, and Other Variables(baseline and mid-treatment)