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DOP030. Feasibility, precision and reproducibility of MR enterography for detection of inflammation in Crohn's Disease in a multicenter clinical trial

J. Rimola1, W.J. Sandborn2, P. Higgins3, A. Coimbra4, T. Lu4, P. Rutgeerts5, D. Luca4, D. Bruining6, S. Vermeire5, J. Panes7, C. Santillan8, M. Al-Hawary9, J. Fidler10, D. Vanbeckevoort11, R. Vanslembrouck11, L. Peyrin-Biroulet12, V. Laurent13, S. O'Byrne4, A. de Crespigny4, 1Hospital Clínic de Barcelona, Radiology Department, Barcelona, Spain, 2University of California San Diego, Division of Gastroenterology, La Jolla, United States, 3University of Michigan, Internal Medicine - Gastroenterology, Ann Arbor, MI, United States, 4Genentech, Research and Early Development, South San Francisco, United States, 5KU Leuven, Division of Gastroenterology, Leuven, Belgium, 6Mayo Clinic, Gastroenterology, Rochester, United States, 7Hospital Clínic Barcelona, Department of Gastroenterology, Barcelona, Spain, 8University of California San Diego, Radiology, San Diego, United States, 9University of Michigan, Radiology, Ann Arbor, United States, 10Mayo Clinic, Radiology, Rochester, United States, 11Biomedical MRI, KU Leuven Department of Imaging and Pathology, Leuven, Belgium, 12Nancy University Hospital, Université de Lorraine, Gastroenterology and Hepatology, Vandoeuvre-les-Nancy, France, 13Brabois Hospital, Gastroenterology, Vandoeuvre les Nancy, France

Background

1) To test the feasibility of MR enterography (MRE) for objective assessment of inflammation in patients with Crohn's Disease (CD) in a global multicenter study; (2) To evaluate test–retest reproducibility of a quantitative MRE-based inflammation score in small bowel (SB); and (3) To assess feasibility and tolerability of MRE with and without a colonic distension enema.

Methods

In total, 19 CD patients gave informed consent to participate in this multicenter (3 USA sites/3 European sites), local IRB-approved study. Within 14 days, each patient underwent 1 ileocolonoscopy (IC) followed by 2 consecutive MREs with or without colonic distention with water enema. The MRE protocol was developed in consensus with the participating sites: sequences included T2-weighted Fast Spin Echo, balanced Gradient Recalled Echo, and T1-weighted series pre- and post-Gd contrast. Tolerability questionnaire was completed following each MRE examination. All MRE images were read centrally and a MaRIA score [1] was assigned for each of 9 bowel segments (4 SB, and 5 colon) as well as a global MaRIA score incorporating all bowel segments. In the study, 332 series across 37 MRE examinations were assessed for quality and a 5-grade quality assessment (QA) score was assigned to each MRE sequence and artifacts annotated. IC videos were centrally read and scored. Precision of MRE score was assessed from the paired repeated measures in 4 SB segments per patient. Overall feasibility of MRE was assessed by compliance to protocol and QA. MRE and IC concordance was assessed using correlation analysis. Impact of colonic distension was evaluated by assessing agreement of MRE quantification of active disease using IC as the standard reference.

Results

The compliance to the predefined MRE protocol was 97%; 86% of series scored good to excellent in quality and 97% scored fair or better in quality. Test–retest MRE scores in SB segments showed an intra-class correlation of 0.96. Analysis of variance confirmed between site variability accounted for less than 1% of the overall variability between the two MRE measurements. The two sets of MaRIA scores from the colon segments, with and without colonic contrast, show significant correlations with CDEIS (r = 0.57, p = 0.018 and r = 0.59, p = 0.013 respectively), but not with CDAI (r = 0.30, p = 0.24 and r = 0.29, p = 0.26 respectively). The correlation of CDAI with CDEIS was r = 0.14 (p = 0.57). Tolerability of MRE was comparable to IC, with patients slightly favoring MRE without enema.

Conclusion

High quality MRE data can be acquired from a uniform MRI scanning protocol in a global multicenter setting. MRE is tolerable and inflammation scores are highly reproducible in SB.

1. J Rimola, S Rodriguez, O Garcia-Bosch, I Ordas, E Ayala, M Aceituno, M Pellise, C Ayuso, E Ricart, L Donoso, J Panes, (2009), Magnetic resonance for assessment of disease activity and severity in ileocolonic Crohn's disease, Gut, 1113–1120