Nicholas Petrick1, Hyun J Grace Kim2, David Clunie3, Kristin Borradaile3, Robert Ford4, Rongping Zeng5, Marios A Gavrielides5, Michael F McNitt-Gray6, Z Q John Lu7, Charles Fenimore7, Binsheng Zhao8, Andrew J Buckler9. 1. Center for Devices and Radiological Health, U.S. Food and Drug Administration, WO62-4118, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002. Electronic address: nicholas.petrick@fda.hhs.gov. 2. Department of Radiological Sciences, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, California; Department of Biostatistics, Fielding School of a Public Health at University of California Los Angeles, Los Angeles, California. 3. CoreLab Partners, Inc., Princeton, NJ. 4. Clinical Trials Imaging Consulting, LLC., Belle Mead, New Jersey. 5. Center for Devices and Radiological Health, U.S. Food and Drug Administration, WO62-4118, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002. 6. Department of Radiological Sciences, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, California. 7. National Institute of Standards and Technology, Gaithersburg, MD. 8. Department of Radiology, Columbia University Medical Center, New York, New York. 9. Elucid Bioimaging Inc., Wenham, MA.
Abstract
RATIONALE AND OBJECTIVES: To estimate and statistically compare the bias and variance of radiologists measuring the size of spherical and complex synthetic nodules. MATERIALS AND METHODS: This study did not require the institutional review board approval. Six radiologists estimated the size of 10 synthetic nodules embedded within an anthropomorphic thorax phantom from computed tomography scans at 0.8- and 5-mm slice thicknesses. The readers measured the nodule size using unidimensional (1D) longest in-slice dimension, bidimensional (2D) area from longest in-slice and longest perpendicular dimension, and three-dimensional (3D) semiautomated volume. Intercomparisons of bias (difference between average and true size) and variance among methods were performed after converting the 2D and 3D estimates to a compatible 1D scale. RESULTS: The relative biases of radiologists with the 3D tool were -1.8%, -0.4%, -0.7%, -0.4%, and -1.6% for 10-mm spherical, 20-mm spherical, 20-mm elliptical, 10-mm lobulated, and 10-mm spiculated nodules compared to 1.4%, -0.1%, -26.5%, -7.8%, and -39.8% for 1D. The three-dimensional measurements were significantly less biased than 1D for elliptical, lobulated, and spiculated nodules. The relative standard deviations for 3D were 7.5%, 3.9%, 3.6%, 9.7%, and 8.3% compared to 5.7%, 2.6%, 20.3%, 5.3%, and 16.4% for 1D. Unidimensional sizing was significantly less variable than 3D for the lobulated nodule and significantly more variable for the ellipsoid and spiculated nodules. Three-dimensional bias and variability were smaller for thin 0.8-mm slice data compared to thick 5.0-mm data. CONCLUSIONS: The study shows that radiologist-controlled 3D volumetric lesion sizing can not only achieve smaller bias but also achieve similar or smaller variability compared to 1D sizing, especially for complex lesion shapes. Published by Elsevier Inc.
RATIONALE AND OBJECTIVES: To estimate and statistically compare the bias and variance of radiologists measuring the size of spherical and complex synthetic nodules. MATERIALS AND METHODS: This study did not require the institutional review board approval. Six radiologists estimated the size of 10 synthetic nodules embedded within an anthropomorphic thorax phantom from computed tomography scans at 0.8- and 5-mm slice thicknesses. The readers measured the nodule size using unidimensional (1D) longest in-slice dimension, bidimensional (2D) area from longest in-slice and longest perpendicular dimension, and three-dimensional (3D) semiautomated volume. Intercomparisons of bias (difference between average and true size) and variance among methods were performed after converting the 2D and 3D estimates to a compatible 1D scale. RESULTS: The relative biases of radiologists with the 3D tool were -1.8%, -0.4%, -0.7%, -0.4%, and -1.6% for 10-mm spherical, 20-mm spherical, 20-mm elliptical, 10-mm lobulated, and 10-mm spiculated nodules compared to 1.4%, -0.1%, -26.5%, -7.8%, and -39.8% for 1D. The three-dimensional measurements were significantly less biased than 1D for elliptical, lobulated, and spiculated nodules. The relative standard deviations for 3D were 7.5%, 3.9%, 3.6%, 9.7%, and 8.3% compared to 5.7%, 2.6%, 20.3%, 5.3%, and 16.4% for 1D. Unidimensional sizing was significantly less variable than 3D for the lobulated nodule and significantly more variable for the ellipsoid and spiculated nodules. Three-dimensional bias and variability were smaller for thin 0.8-mm slice data compared to thick 5.0-mm data. CONCLUSIONS: The study shows that radiologist-controlled 3D volumetric lesion sizing can not only achieve smaller bias but also achieve similar or smaller variability compared to 1D sizing, especially for complex lesion shapes. Published by Elsevier Inc.
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