Quantitative Imaging Assessment for Clinical Trials in Oncology
University of Michigan Rogel Cancer Center; and
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Department of Radiology, University of Michigan Medical School, Ann Arbor, Michigan.
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Department of Radiology, University of Michigan Medical School, Ann Arbor, Michigan.
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Department of Internal Medicine, University of Michigan Medical School;
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Background: Objective radiographic assessment is crucial for accurately evaluating therapeutic efficacy and patient outcomes in oncology clinical trials. Imaging assessment workflow can be complex; can vary with institution; may burden medical oncologists, who are often inadequately trained in radiology and response criteria; and can lead to high interobserver variability and investigator bias. This article reviews the development of a tumor response assessment core (TRAC) at a comprehensive cancer center with the goal of providing standardized, objective, unbiased tumor imaging assessments, and highlights the web-based platform and overall workflow. In addition, quantitative response assessments by the medical oncologists, radiologist, and TRAC are compared in a retrospective cohort of patients to determine concordance. Patients and Methods: The TRAC workflow includes an image analyst who pre-reviews scans before review with a board-certified radiologist and then manually uploads annotated data on the proprietary TRAC web portal. Patients previously enrolled in 10 lung cancer clinical trials between January 2005 and December 2015 were identified, and the prospectively collected quantitative response assessments by the medical oncologists were compared with retrospective analysis of the same dataset by a radiologist and TRAC. Results: This study enlisted 49 consecutive patients (53% female) with a median age of 60 years (range, 29–78 years); 2 patients did not meet study criteria and were excluded. A linearly weighted kappa test for concordance for TRAC versus radiologist was substantial at 0.65 (95% CI, 0.46–0.85; standard error [SE], 0.10). The kappa value was moderate at 0.42 (95% CI, 0.20–0.64; SE, 0.11) for TRAC versus oncologists and only fair at 0.34 (95% CI, 0.12–0.55; SE, 0.11) for oncologists versus radiologist. Conclusions: Medical oncologists burdened with the task of tumor measurements in patients on clinical trials may introduce significant variability and investigator bias, with the potential to affect therapeutic response and clinical trial outcomes. Institutional imaging cores may help bridge the gap by providing unbiased and reproducible measurements and enable a leaner workflow.
Submitted June 12, 2018; accepted for publication June 18, 2019.
Author contributions: Study design: Hersberger, Sahai. Core design: Hersberger, Fischer, Francis, Olszewski, Harju, Shi, Manion, Sahai. Data acquisition: Hersberger, Mendiratta-Lala, Kaza, Francis, Al-Hawary, Sahai. Statistics: Sahai. Manuscript preparation: Hersberger, Fischer, Harju, Sahai. Manuscript editing: All authors.
Disclosures: The authors have disclosed that they have not received any financial considerations from any person or organization to support the preparation, analysis, results, or discussion of this article.
Funding: Research reported in this publication was supported by the NCI of the NIH under award number P30CA046592. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
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