Abstract
Purpose: To evaluate a novel quantitative methodology to assess inflammatory changes in magnetic resonance imaging (MRI) data from patients with rheumatoid arthritis (RA) and the impact of image quality on imaging outcomes compared to the RA Magnetic Resonance Imaging Score (RAMRIS). Methods: Three-dimensional, T1-weighted, fat-suppressed MRI sequences of the hand/wrist before and after intravenous Gadolinium contrast from patients with RA in a placebo-controlled clinical trial (NCT01185353) were re-evaluated post hoc. The methodology was integrated into proprietary software (DYNAMIKA®) and assessed inflammation through pixelated measurements of the contrast-enhancing (inflammatory) volume. A semi-automatic approach outlined contrast-enhancing synovial tissue in the wrist and second to fifth metacarpophalangeal joints with a rough region of interest (ROI); quantitative imaging biomarkers were generated by means of quantitative total volume of inflammation and quantitative degree of inflammation relative to the signal in a 1 cm in diameter ROI in the center of the thenar or lumbrical muscle for internal reference. The time from Gadolinium injection to finalization of the post-contrast images was calculated from the images’ Digital Imaging and Communications in Medicine header. An experienced reader graded image quality as poor, acceptable, or good. Results: Results from this quantitative methodology, especially when excluding images with poor quality scores (14–32%), provided a more pronounced and monotonically increasing dose-response than the original RAMRIS results on synovitis and osteitis. Conclusions: This computer-aided quantitative scoring method provided continuous measures of inflammatory changes relative to muscle and may be more sensitive and interpretable concerning dose/response separation between RA treatment groups.
Originalsprog | Engelsk |
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Artikelnummer | 109877 |
Tidsskrift | European Journal of Radiology |
Vol/bind | 143 |
Antal sider | 9 |
ISSN | 0720-048X |
DOI | |
Status | Udgivet - 2021 |
Bibliografisk note
Funding Information:Medical writing support was provided by Shannon E. Gardell of Evidera | PPD and funded by Eli Lilly and Company.
Funding Information:
Medical writing support was provided by Shannon E. Gardell of Evidera | PPD and funded by Eli Lilly and Company. Funding for this study was provided by Eli Lilly and Company, which was involved in the study design, data collection, data analysis, and preparation of the manuscript. Eli Lilly provides access to all individual participant data collected during the trial, after anonymization, except for pharmacokinetic or genetic data. Data are available upon request six months after the indication studied has been approved in the United States and European Union and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, and blank or annotated case report forms, will be provided in a secure data-sharing environment. For details on submitting a request, see the instructions provided atwww.vivli.org.
Publisher Copyright:
© 2021 Eli Lilly and Company