skip to main content
OSTI.GOV title logo U.S. Department of Energy
Office of Scientific and Technical Information

Title: Development of a dynamic quality assurance testing protocol for multisite clinical trial DCE-CT accreditation

Abstract

Purpose: Credentialing can have an impact on whether or not a clinical trial produces useful quality data that is comparable between various institutions and scanners. With the recent increase of dynamic contrast enhanced-computed tomography (DCE-CT) usage as a companion biomarker in clinical trials, effective quality assurance, and control methods are required to ensure there is minimal deviation in the results between different scanners and protocols at various institutions. This paper attempts to address this problem by utilizing a dynamic flow imaging phantom to develop and evaluate a DCE-CT quality assurance (QA) protocol.Methods: A previously designed flow phantom, capable of producing predictable and reproducible time concentration curves from contrast injection was fully validated and then utilized to design a DCE-CT QA protocol. The QA protocol involved a set of quantitative metrics including injected and total mass error, as well as goodness of fit comparison to the known truth concentration curves. An additional region of interest (ROI) sensitivity analysis was also developed to provide additional details on intrascanner variability and determine appropriate ROI sizes for quantitative analysis. Both the QA protocol and ROI sensitivity analysis were utilized to test variations in DCE-CT results using different imaging parameters (tube voltage and current) asmore » well as alternate reconstruction methods and imaging techniques. The developed QA protocol and ROI sensitivity analysis was then applied at three institutions that were part of clinical trial involving DCE-CT and results were compared.Results: The inherent specificity of robustness of the phantom was determined through calculation of the total intraday variability and determined to be less than 2.2 ± 1.1% (total calculated output contrast mass error) with a goodness of fit (R{sup 2}) of greater than 0.99 ± 0.0035 (n= 10). The DCE-CT QA protocol was capable of detecting significant deviations from the expected phantom result when scanning at low mAs and low kVp in terms of quantitative metrics (Injected Mass Error 15.4%), goodness of fit (R{sup 2}) of 0.91, and ROI sensitivity (increase in minimum input function ROI radius by 146 ± 86%). These tests also confirmed that the ASIR reconstruction process was beneficial in reducing noise without substantially increasing partial volume effects and that vendor specific modes (e.g., axial shuttle) did not significantly affect the phantom results. The phantom and QA protocol were finally able to quickly (<90 min) and successfully validate the DCE-CT imaging protocol utilized at the three separate institutions of a multicenter clinical trial; thereby enhancing the confidence in the patient data collected.Conclusions: A DCE QA protocol was developed that, in combination with a dynamic multimodality flow phantom, allows the intrascanner variability to be separated from other sources of variability such as the impact of injection protocol and ROI selection. This provides a valuable resource that can be utilized at various clinical trial institutions to test conformance with imaging protocols and accuracy requirements as well as ensure that the scanners are performing as expected for dynamic scans.« less

Authors:
 [1];  [2]; ;  [1]
  1. Department of Radiation Physics, Princess Margaret Cancer Center, 610 University Avenue, Toronto, Ontario M5G 2M9 (Canada)
  2. Department of Radiation Physics, Princess Margaret Cancer Center, 610 University Avenue, Toronto, Ontario M5G 2M9, Canada and Department of Radiation Oncology, University of Toronto, 150 College Street, Toronto, Ontario M5S 3E2 (Canada)
Publication Date:
OSTI Identifier:
22220515
Resource Type:
Journal Article
Journal Name:
Medical Physics
Additional Journal Information:
Journal Volume: 40; Journal Issue: 8; Other Information: (c) 2013 American Association of Physicists in Medicine; Country of input: International Atomic Energy Agency (IAEA); Journal ID: ISSN 0094-2405
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; BIOLOGICAL MARKERS; CLINICAL TRIALS; COMPUTERIZED TOMOGRAPHY; ERRORS; IMAGE PROCESSING; PHANTOMS; QUALITY ASSURANCE; QUALITY CONTROL; SENSITIVITY ANALYSIS

Citation Formats

Driscoll, B., Keller, H., Jaffray, D., Coolens, C., Department of Radiation Oncology, University of Toronto, 150 College Street, Toronto, Ontario M5S 3E2, and Techna Institute, University Health Network, 124-100 College Street, Toronto, Ontario M5G 1L5. Development of a dynamic quality assurance testing protocol for multisite clinical trial DCE-CT accreditation. United States: N. p., 2013. Web. doi:10.1118/1.4812429.
Driscoll, B., Keller, H., Jaffray, D., Coolens, C., Department of Radiation Oncology, University of Toronto, 150 College Street, Toronto, Ontario M5S 3E2, & Techna Institute, University Health Network, 124-100 College Street, Toronto, Ontario M5G 1L5. Development of a dynamic quality assurance testing protocol for multisite clinical trial DCE-CT accreditation. United States. https://doi.org/10.1118/1.4812429
Driscoll, B., Keller, H., Jaffray, D., Coolens, C., Department of Radiation Oncology, University of Toronto, 150 College Street, Toronto, Ontario M5S 3E2, and Techna Institute, University Health Network, 124-100 College Street, Toronto, Ontario M5G 1L5. 2013. "Development of a dynamic quality assurance testing protocol for multisite clinical trial DCE-CT accreditation". United States. https://doi.org/10.1118/1.4812429.
@article{osti_22220515,
title = {Development of a dynamic quality assurance testing protocol for multisite clinical trial DCE-CT accreditation},
author = {Driscoll, B. and Keller, H. and Jaffray, D. and Coolens, C. and Department of Radiation Oncology, University of Toronto, 150 College Street, Toronto, Ontario M5S 3E2 and Techna Institute, University Health Network, 124-100 College Street, Toronto, Ontario M5G 1L5},
abstractNote = {Purpose: Credentialing can have an impact on whether or not a clinical trial produces useful quality data that is comparable between various institutions and scanners. With the recent increase of dynamic contrast enhanced-computed tomography (DCE-CT) usage as a companion biomarker in clinical trials, effective quality assurance, and control methods are required to ensure there is minimal deviation in the results between different scanners and protocols at various institutions. This paper attempts to address this problem by utilizing a dynamic flow imaging phantom to develop and evaluate a DCE-CT quality assurance (QA) protocol.Methods: A previously designed flow phantom, capable of producing predictable and reproducible time concentration curves from contrast injection was fully validated and then utilized to design a DCE-CT QA protocol. The QA protocol involved a set of quantitative metrics including injected and total mass error, as well as goodness of fit comparison to the known truth concentration curves. An additional region of interest (ROI) sensitivity analysis was also developed to provide additional details on intrascanner variability and determine appropriate ROI sizes for quantitative analysis. Both the QA protocol and ROI sensitivity analysis were utilized to test variations in DCE-CT results using different imaging parameters (tube voltage and current) as well as alternate reconstruction methods and imaging techniques. The developed QA protocol and ROI sensitivity analysis was then applied at three institutions that were part of clinical trial involving DCE-CT and results were compared.Results: The inherent specificity of robustness of the phantom was determined through calculation of the total intraday variability and determined to be less than 2.2 ± 1.1% (total calculated output contrast mass error) with a goodness of fit (R{sup 2}) of greater than 0.99 ± 0.0035 (n= 10). The DCE-CT QA protocol was capable of detecting significant deviations from the expected phantom result when scanning at low mAs and low kVp in terms of quantitative metrics (Injected Mass Error 15.4%), goodness of fit (R{sup 2}) of 0.91, and ROI sensitivity (increase in minimum input function ROI radius by 146 ± 86%). These tests also confirmed that the ASIR reconstruction process was beneficial in reducing noise without substantially increasing partial volume effects and that vendor specific modes (e.g., axial shuttle) did not significantly affect the phantom results. The phantom and QA protocol were finally able to quickly (<90 min) and successfully validate the DCE-CT imaging protocol utilized at the three separate institutions of a multicenter clinical trial; thereby enhancing the confidence in the patient data collected.Conclusions: A DCE QA protocol was developed that, in combination with a dynamic multimodality flow phantom, allows the intrascanner variability to be separated from other sources of variability such as the impact of injection protocol and ROI selection. This provides a valuable resource that can be utilized at various clinical trial institutions to test conformance with imaging protocols and accuracy requirements as well as ensure that the scanners are performing as expected for dynamic scans.},
doi = {10.1118/1.4812429},
url = {https://www.osti.gov/biblio/22220515}, journal = {Medical Physics},
issn = {0094-2405},
number = 8,
volume = 40,
place = {United States},
year = {Thu Aug 15 00:00:00 EDT 2013},
month = {Thu Aug 15 00:00:00 EDT 2013}
}