In:
Alimentary Pharmacology & Therapeutics, Wiley, Vol. 43, No. 1 ( 2016-01), p. 61-72
Abstract:
Reliable tools for patient selection are critical for clinical drug trials. Aim To evaluate a consensus‐based, standardised magnetic resonance enterography ( MRE ) protocol for selecting patients for inclusion in Crohn's disease ( CD ) multicenter clinical trials. Methods This study recruited 20 patients [Crohn's Disease Activity Index (CDAI) scores: 〈 150 ( n = 8); 150–220 ( n = 4); 220–450 ( n = 8)], to undergo ileocolonoscopy and two MRE s (with and without colonic contrast) within a 14‐day period. Procedures were scored centrally using, Magnetic Resonance Index of Activity (Ma RIA ), and both Crohn's Disease Endoscopic Index of Severity ( CDEIS ) and Simplified Endoscopic Score ( SES ‐ CD ). Results 37 MRE s were acquired. Both MRE s were evaluable in 16 patients for calculation of test–retest and inter‐reader reliability scores. The Ma RIA scores for the terminal ileum had excellent test–retest and inter‐reader reliability, with correlations 〉 0.9. The proximal ileum showed strong within‐reader agreement (0.90–0.96), and fair between‐reader agreement (0.59–0.72). MRE procedures were tolerable. Ma RIA scores correlated with CDEIS and SES ‐ CD (0.63 and 0.71), but not with CDAI (0.34). MRE identified 3 patients with intra‐abdominal complications, who would otherwise have been included in clinical trials. Furthermore, both MRE and ileocolonoscopy identified active bowel wall inflammation in 2 patients with CDAI 〈 150, and none in 1 patient with CDAI 〉 220. Data quality was good/excellent in 85% of scans, and fair or better in 96%. Conclusions Magnetic resonance enterography of high‐quality and reproducibility was feasible in a global multi‐ centre setting, with evidence for improved selectivity over CDAI and ileocolonoscopy in identifying appropriate CD patients for inclusion in therapeutic intervention trials.
Type of Medium:
Online Resource
ISSN:
0269-2813
,
1365-2036
DOI:
10.1111/apt.2016.43.issue-1
Language:
English
Publisher:
Wiley
Publication Date:
2016
detail.hit.zdb_id:
2003094-0
SSG:
15,3
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