Automated Tracking of Quantitative Assessments of Tumor Burden in Clinical Trials

Automated Tracking of Quantitative Assessments of Tumor Burden in Clinical Trials
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DOI:
10.1593/tlo.13796
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发表时间:
2014-02-01
影响因子:
5
通讯作者:
Moreira, Dilvan A.
Moreira, Dilvan A.
中科院分区:
医学3区
文献类型:
--
作者:
Rubin, Daniel L.;Willrett, Debra;Moreira, Dilvan A.

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在癌症反应评估中,有两个关键挑战阻碍了影像定量评估的有效应用:1)放射科医生在影像研究中对肿瘤病变的描述通常是主观的,有时是模棱两可的,2)很难重新调整成像数据的用途,因为病变测量的记录格式不允许机器解释和互操作。我们在开放标准的基础上开发了一个免费可用的软件平台,即电子医生注释设备(EPad),以两种方式应对这些挑战。首先,ePad便于放射科医生进行癌症病变测量,作为常规临床试验图像解释工作流程的一部分。其次,ePad以一种数据格式记录所有图像测量和注释,该格式允许重新调整图像数据的用途,以分析治疗反应的替代成像生物标志物。为了确定ePad在成像研究定量评估中对放射科医生效率的影响,放射科医生评估了20名受试者的计算机断层扫描(CT)成像研究,这些受试者具有一个基线和三个连续的使用和不使用ePad的后续成像研究。放射科医生在每个成像研究中使用实体肿瘤反应评估标准1.1标准测量目标损害,最初是在ePad的帮助下,然后在30天的洗涤期后,在没有ePad的情况下重新阅读检查。使用ePad检查图像和总结目标病变的测量结果所需的平均总时间比不使用该工具缩短了15%(P<0.039)。此外,可以快速重新分析图像以探索病变横截面积,作为线性测量的替代成像生物标记物。我们的结论是,ePad似乎有望提高CT检查定量评估的阅读器效率,并可能发现未来基于图像的癌症治疗反应的新生物标记物。
There are two key challenges hindering effective use of quantitative assessment of imaging in cancer response assessment: 1) Radiologists usually describe the cancer lesions in imaging studies subjectively and sometimes ambiguously, and 2) it is difficult to repurpose imaging data, because lesion measurements are not recorded in a format that permits machine interpretation and interoperability. We have developed a freely available software platform on the basis of open standards, the electronic Physician Annotation Device (ePAD), to tackle these challenges in two ways. First, ePAD facilitates the radiologist in carrying out cancer lesion measurements as part of routine clinical trial image interpretation workflow. Second, ePAD records all image measurements and annotations in a data format that permits repurposing image data for analyses of alternative imaging biomarkers of treatment response. To determine the impact of ePAD on radiologist efficiency in quantitative assessment of imaging studies, a radiologist evaluated computed tomography (CT) imaging studies from 20 subjects having one baseline and three consecutive follow-up imaging studies with and without ePAD. The radiologist made measurements of target lesions in each imaging study using Response Evaluation Criteria in Solid Tumors 1.1 criteria, initially with the aid of ePAD, and then after a 30-day washout period, the exams were reread without ePAD. The mean total time required to review the images and summarize measurements of target lesions was 15% (P < .039) shorter using ePAD than without using this tool. In addition, it was possible to rapidly reanalyze the images to explore lesion cross-sectional area as an alternative imaging biomarker to linear measure. We conclude that ePAD appears promising to potentially improve reader efficiency for quantitative assessment of CT examinations, and it may enable discovery of future novel image-based biomarkers of cancer treatment response.