I-SPY 2 Breast Dynamic Contrast Enhanced MRI Trial

<p>I-SPY 2 (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2) is an ongoing, multi-center trial (<a href="https://clinicaltrials.gov/ct2/show/NCT01042379">NCT01042379</a>) designed to quickly evaluate the efficacy of new agents for breast cancer in neoadjuvant chemotherapy (NAC) setting. Women aged ≥18 years diagnosed with locally advanced breast cancer (tumor size ≥2.5 cm) without distant metastasis are eligible to enroll in the trial. Patients with breast cancer at high-risk for recurrence are adaptively-randomized to either control arm (standard NAC) or one of several concurrent experimental drug arms. I-SPY 2 utilizes change in tumor volume by DCE-MRI at serial time-points during NAC to adjust the randomization schema as the trial proceeds, preferentially assigning patients to receive agents showing an increasing likelihood of efficacy against their breast cancer subtype. I-SPY 2 opened in Spring 2010 and is ongoing.</p><p>This collection includes DCE MRI data (original acquired images and derived parametric maps) for I-SPY 2 patients adaptively randomized between 2010 and 2016, along with histopathologic outcome data. Breast MRI data in this collection was acquired prospectively at over 22 clinical centers using a standardized image acquisition protocol. Patients underwent 4 MRI exams before and during NAC and over 95% of the DCE imaging data met acceptance criteria for analysis of functional tumor volume (FTV), a demonstrated quantitative imaging marker of breast cancer response to NAC. This is a comprehensive, highly curated imaging data set with histopathologic outcome that can be used to develop, test and compare imaging metrics and prediction models for breast cancer response to treatment. Original but uncurated T2<sub>weighted</sub> MRI images are also included for most studies.</p><p>719 patients are included in this collection. In combination with 266 patients from the <a href="/collection/acrin-6698/">ACRIN 6698/I-SPY2 Breast DWI</a> Collection these 985 patients comprise "I-SPY2 Imaging Cohort 1", the 1st subgroup of publicly released imaging data from the I-SPY 2 TRIAL. All subjects in the I-SPY2 Imaging Cohort 1 were enrolled in I-SPY 2 from 2010 to 2016 and randomized to one of nine completed experimental drug arms or control arm. In order to obtain the MRI data for the entire I-SPY2 Imaging Cohort 1 please download using the manifest file provided in the Data Access table below as this will include the patients from both collections. Downloading this collection alone will result in an incomplete cohort of 719 patients and any results from that patient set will not be comparable to published results from the trial.</p><p>In addition, a retrospective study using a 384 patient subset (median age: 49 y/o) was performed to test if prediction models combining multiple MRI features outperform models with single features. Four features were quantitatively calculated in each MRI exam: functional tumor volume, longest diameter, sphericity, and contralateral background parenchymal enhancement. Logistic regression analysis was used to study the relationship between MRI variables and pathologic complete response (pCR). Predictive performance was estimated using the area under the receiver operating characteristic curve (AUC). The cohort was stratified by hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status (positive or negative). Results showed analysis with combined features achieved higher AUCs than analysis with any feature alone.  These results are further described in the associated <a href="https://doi.org/10.1038/s41523-020-00203-7"> publication </a>and in the multi-feature MRI spreadsheet included with this Collection.</p><h3>I-SPY2 Imaging Biomarker Group</h3><p>We are establishing the I-SPY 2 ​Imaging ​Biomarker ​Subgroup to provide a forum where imaging scientists and radiologists can explore,​ discuss, and strategize on the use of I-SPY 2 MRI data ​available through TCIA. ​Please access <a href="https://forms.office.com/r/u0xzwB9kbU">https://forms.office.com/r/u0xzwB9kbU</a> to be considered to join our bimonthly Zoom meeting invite list.</p>

I-SPY 2（通过影像与分子分析预测您治疗反应的系列研究2）是一项持续进行的、多中心的临床试验（临床试验编号：NCT01042379），旨在快速评估新药在辅助化疗（NAC）设置中对乳腺癌的治疗效果。年龄≥18岁、被诊断为局部晚期乳腺癌（肿瘤大小≥2.5厘米）且无远处转移的女性符合入组条件。患有乳腺癌且复发风险较高的患者将被适应性随机分配到对照组（标准NAC）或多个同时进行的实验药物组之一。I-SPY 2通过在NAC期间连续时间点使用DCE-MRI检测肿瘤体积的变化，随着试验的进行调整随机化方案，优先将患者分配给显示出对其乳腺癌亚型治疗效果增加可能性的药物。I-SPY 2于2010年春季启动，并持续进行中。

本集合包括2010年至2016年间适应性随机分配到I-SPY 2患者的DCE MRI数据（原始获取图像和派生参数图），以及组织病理学结果数据。本集合中的乳腺MRI数据是在超过22个临床中心使用标准图像采集方案前瞻性获取的。患者在NAC前后进行4次MRI检查，超过95%的DCE成像数据符合分析功能性肿瘤体积（FTV）的接受标准，FTV是乳腺癌对NAC反应的已证实的定量影像学标志。这是一个包含组织病理学结果的全面、高度精选的影像数据集，可用于开发、测试和比较乳腺癌治疗反应的影像学指标和预测模型。大多数研究中还包括原始但未经精选的T2加权MRI图像。

本集合包括719名患者。结合来自<a href=

搜集汇总

背景与挑战

背景概述

该数据集来自I-SPY 2多中心临床试验，包含719名乳腺癌患者的动态对比增强MRI数据和组织病理学结果，采集于2010年至2016年，采用标准化协议。它是一个高度策划的成像数据集，旨在支持乳腺癌治疗反应的成像指标和预测模型的开发与测试，具有多中心来源和丰富的临床关联性。