Abstract

PurposeThis study aimed to develop a physical geometric phantom for the deformable image registration (DIR) credentialing of radiotherapy centers for a clinical trial and tested the feasibility of the proposed phantom at multiple domestic and international institutions.Methods and materialsThe phantom reproduced tumor shrinkage, rectum shape change, and body shrinkage using several physical phantoms with custom inserts. We tested the feasibility of the proposed phantom using 5 DIR patterns at 17 domestic and 2 international institutions (21 datasets). Eight institutions used the MIM software (MIM Software Inc, Cleveland, OH); seven used Velocity (Varian Medical Systems, Palo Alto, CA), and six used RayStation (RaySearch Laboratories, Stockholm, Sweden). The DIR accuracy was evaluated using the Dice similarity coefficient (DSC) and Hausdorff distance (HD).ResultsThe mean and one standard deviation (SD) values (range) of DSC were 0.909 ± 0.088 (0.434–0.984) and 0.909 ± 0.048 (0.726–0.972) for tumor and rectum proxies, respectively. The mean and one SD values (range) of the HD value were 5.02 ± 3.32 (1.53–20.35) and 5.79 ± 3.47 (1.22–21.48) (mm) for the tumor and rectum proxies, respectively. In three patterns evaluating the DIR accuracy within the entire phantom, 61.9% of the data had more than a DSC of 0.8 in both tumor and rectum proxies. In two patterns evaluating the DIR accuracy by focusing on tumor and rectum proxies, all data had more than a DSC of 0.8 in both tumor and rectum proxies.ConclusionsThe wide range of DIR performance highlights the importance of optimizing the DIR process. Thus, the proposed method has considerable potential as an evaluation tool for DIR credentialing and quality assurance.

Highlights

  • Worldwide, audit systems have been established for credentialing institutions for participant clinical trials

  • We developed a physical geometric phantom for the deformable image registration (DIR) credentialing of radiotherapy centers for a clinical trial and tested the feasibility of implementing the proposed phantom at multiple domestic and international institutions

  • End-to-end DIR credentialing was performed on 21 DIR software at 19 participating institutions in 2019 and 2020

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Summary

Introduction

Audit systems have been established for credentialing institutions for participant clinical trials. Unacceptable differences in doses and image guidance potentially influence clinical outcomes.[1,2] dose delivery and image guidance are evaluated by credentialing institutions for various clinical trials.[3,4,5]. Deformable image registration (DIR) has become essential in radiotherapy, including multimodality image fusion and dose accumulation.[6,7,8] Phase I clinical trials in which a treatment is adapted every ten fractions use the DIR-based dose accumulation for evaluating treatment outcomes as well as reporting.[7] Several studies have shown that the DIR accuracy greatly depends on both the DIR software and procedure (e.g., DIR parameter settings).[9,10,11] DIR credentialing is necessary to achieve more reliable clinical trial results

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