Total risk index: a mathematical model for decision making based on clinical and radiation risk assessment in CT

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2019-12-04

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Abstract

Purpose. Radiological risk is a combination of radiation and clinical risk (likelihood of not delivering a proper diagnosis), which together may be characterized as a total risk index (TRI). While many strategies have been developed to ascertain radiation risk, there has been a paucity of studies assessing the clinical risk. This knowledge gap makes impossible to determine the total radiological procedure risk and, thus, to perform a comprehensive optimization. The purpose of this study was to develop a mathematical model to ascertain TRI and to identify the minimum TRI (mTRI) in a clinical CT population.

Materials and Methods. This IRB approved study included 21 adults abdomen exams performed on a dual-source single energy CT at two different dose levels (84 CT series). Virtual liver lesions were inserted into projection data to simulate localized stage liver cancer (LSLC). The detectability index (d') was calculated in each series and converted to percentage of correct observer answers (AUC) in a two-alternative forced-choice model. The AUC was converted into the loss of 5-year relative survival rate (SEER, NCI), considering an upper bound on patient's risk for a misdiagnosis of LSLC (false positive + false negative). Concerning radiation risk, organ doses were estimated using a Monte Carlo method and the Risk Index was calculated and converted in 5-year relative survival rate for cancer. Finally, the two risks were weighted equally into a combined TRI curve per each patient as a function of CTDIvol. The analytical minimum of each TRI curve provided the patient mTRI.

Results. The mTRI for LSLC patients that underwent an abdominal CT exhibited a rapid rise at low radiation dose due to enhanced clinical risk of under-dosed examinations. Increasing dose offered less risk with mortality per 100 patients between 2.1 and 6.5 (mean 4.5) at CTDIvol=5mGy, between 1.1 and 5.9 (mean 3.5) at CTDIvol=10mGy and between 0.5 and 5.4 (mean 3.0) at CTDIvol=20 mGy.

Conclusion. The clinical risk seems to play a more dominant factor in designing optimum CT protocols. The TRI may provide an objective and quantifiable metric of the interplay of radiation and clinical risks during the optimization of the CT technique for individual patients.

Clinical Relevance statement. CT risk-based optimization can be made possible by first quantifying both radiation and clinical risk using comparable units, then calculating an overall risk, and finally minimizing the total risk.

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Scholars@Duke

Ria

Francesco Ria

Assistant Professor of Radiology

Dr. Francesco Ria is a medical physicist and he serves as an Assistant Professor in the Department of Radiology. Francesco has an extensive expertise in the assessment of procedure performances in radiology. In particular, his research activities focus on the simultaneous evaluation of radiation dose and image quality in vivo in computed tomography providing a comprehensive evaluation of radiological exams. Moreover, Francesco is developing and investigating novel mathematical models that, uniquely in the radiology field, can incorporate a comprehensive and quantitative risk-to-benefit assessment of the procedures; he is continuing to apply his expertise towards the definition of new patient specific risk metrics, and in the assessment of image quality in vivo also using state-of-the-art imaging technology, such as photon counting computed tomography scanners, and machine learning reconstruction algorithms.

Dr. Ria is a member of the American Association of Physicists in Medicine task group 392 (Investigation and Quality Control of Automatic Exposure Control System in CT), of the American Association of Physicists in Medicine Public Education working group (WGATE), and of the Italian Association of Medical Physics task group Dose Monitoring in Diagnostic Imaging.

Samei

Ehsan Samei

Reed and Martha Rice Distinguished Professor of Radiology

Dr. Ehsan Samei, PhD, DABR, FAAPM, FSPIE, FAIMBE, FIOMP, FACR is a Persian-American medical physicist. He is the Reed and Martha Rice Distinguished Professor of Radiology, and Professor of Medical Physics, Biomedical Engineering, Physics, and Electrical and Computer Engineering at Duke University. He serves as the Chief Imaging Physicist for Duke University Health System, the Director of the Carl E Ravin Advanced Imaging Laboratories and the Center for Virtual Imaging Trials (CVIT), and co-PI of one the five Centers of Excellence in Regulatory Science and Innovation (CERSI), Triangle CERSI. He is certified by the American Board of Radiology, recognized as a Distinguished Investigator by the Academy of Radiology Research, and awarded Fellow by five professional organization. He founded/co-founded the Duke Medical Physics Program, the Duke Imaging Physics Residency Program, the Duke Clinical Imaging Physics Group, the Center for Virtual Imaging Trials, and the Society of Directors of Academic Medical Physics Programs (SDAMPP). He has held senior leadership positions in the AAPM, SPIE, SDAMPP, and RSNA, including election to the presidency of the SEAAPM (2010-2011), SDAMPP (2011), and AAPM (2023).

Dr. Samei’s scientific expertise include x-ray imaging, theoretical imaging models, simulation methods, and experimental techniques in medical image formation, quantification, and perception.  His research aims to bridge the gap between scientific scholarship and clinical practice, in the meaningful realization of translational research, and in clinical processes that are informed by scientific evidence. He has advanced image quality and safety metrics and radiometrics that are clinically relevant and that can be used to design, optimize, and monitor interpretive and quantitative performance of imaging techniques. These have been implemented in advanced imaging performance characterization, procedural optimization, and clinical dose and quality analytics. His most recent research interests have been virtual clinical trial across a broad spectrum of oncologic, pulmonary, cardiac, and vascular diseases, and developing methodological advances that provide smart fusions of principle-informed and AI-based, data-informed approaches to scientific inquiry.

Dr. Samei has mentored over 140 trainees (graduate and postgraduate). He has >1400 scientific publications including >360 referred journal articles, ~600 conference presentations, and 4 books. Citations to his work is reflected in an h-index of 74 and a Weighted Relative Citation Ratio of 613. His laboratory of over 20 researchers has been supported continuously over two decades by 44 extramural grants, culminating in a NIH Program Project grant in 2021 to establish the national Center for Virtual Imaging Trials (CVIT), joining a small number of prominent Biomedical Technology Research Centers across the nation. In 2023, he, along with 3 other PIs, was awarded to lead one of five national Centers of Excellence in Regulatory Science and Innovation (Triangle CERSI) by the FDA.


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