title: Magnetic resonance enterography is feasible and reliable in multicenter clinical trials in patients with Crohn's disease, and may help select subjects with active inflammation.
abstract: BACKGROUND
  Reliable tools for patient selection are critical for clinical drug trials.
  
  
  OBJECTIVE
  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 MREs (with and without colonic contrast) within a 14-day period. Procedures were scored centrally using, Magnetic Resonance Index of Activity (MaRIA), and both Crohn's Disease Endoscopic Index of Severity (CDEIS) and Simplified Endoscopic Score (SES-CD).
  
  
  RESULTS
  37 MREs were acquired. Both MREs were evaluable in 16 patients for calculation of test-retest and inter-reader reliability scores. The MaRIA 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. MaRIA 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.
authors.affiliation: Genentech, Inc., South San Francisco, CA, USA.
authors.forename: A J F
authors.initials: AJ
authors.lastname: Coimbra
authors.affiliation: Hospital Clínic de Barcelona, Catalonia, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Rimola
authors.affiliation: Genentech, Inc., South San Francisco, CA, USA.
authors.forename: S
authors.initials: S
authors.lastname: O'Byrne
authors.affiliation: Genentech, Inc., South San Francisco, CA, USA.
authors.forename: T T
authors.initials: TT
authors.lastname: Lu
authors.affiliation: Genentech, Inc., South San Francisco, CA, USA.
authors.forename: T
authors.initials: T
authors.lastname: Bengtsson
authors.affiliation: Genentech, Inc., South San Francisco, CA, USA.
authors.forename: A
authors.initials: A
authors.lastname: de Crespigny
authors.affiliation: Genentech, Inc., South San Francisco, CA, USA.
authors.forename: D
authors.initials: D
authors.lastname: Luca
authors.affiliation: University Hospitals Leuven, Leuven, Belgium.
authors.forename: P
authors.initials: P
authors.lastname: Rutgeerts
authors.affiliation: Mayo Clinic, Rochester, MN, USA.
authors.forename: D H
authors.initials: DH
authors.lastname: Bruining
authors.affiliation: Mayo Clinic, Rochester, MN, USA.
authors.forename: J L
authors.initials: JL
authors.lastname: Fidler
authors.affiliation: University of California San Diego, La Jolla, CA, USA.
authors.forename: W J
authors.initials: WJ
authors.lastname: Sandborn
authors.affiliation: University of California San Diego, La Jolla, CA, USA.
authors.forename: C S
authors.initials: CS
authors.lastname: Santillan
authors.affiliation: University of Michigan, Ann Arbor, MI, USA.
authors.forename: P D R
authors.initials: PD
authors.lastname: Higgins
authors.affiliation: University of Michigan, Ann Arbor, MI, USA.
authors.forename: M M
authors.initials: MM
authors.lastname: Al-Hawary
authors.affiliation: TARGID, KU Leuven, Leuven, Belgium.
authors.forename: S
authors.initials: S
authors.lastname: Vermeire
authors.affiliation: University Hospital Leuven, Leuven, Belgium.
authors.forename: D
authors.initials: D
authors.lastname: Vanbeckevoort
authors.affiliation: University Hospital Leuven, Leuven, Belgium.
authors.forename: R
authors.initials: R
authors.lastname: Vanslembrouck
authors.affiliation: University Hospital of Nancy-Brabois, Université de Lorraine, Vandoeuvre-lès-Nancy, France.
authors.forename: L
authors.initials: L
authors.lastname: Peyrin-Biroulet
authors.affiliation: Adults University, Nancy University, Vandoeuvre-lès-Nancy, France.
authors.forename: V
authors.initials: V
authors.lastname: Laurent
authors.affiliation: University Hospitals Case Medical Center and Case Western Reserve University, Cleveland, OH, USA.
authors.forename: K A
authors.initials: KA
authors.lastname: Herrmann
authors.affiliation: Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Panes
mesh_terms: D000328:Adult; D003106:Colon / Q000473:pathology; D003424:Crohn Disease / Q000473:pathology*; D016099:Endoscopy, Gastrointestinal / Q000379:methods* / Q000592:standards; D005260:Female; D006801:Humans; D007082:Ileum / Q000473:pathology; D007249:Inflammation / Q000473:pathology; D009682:Magnetic Resonance Spectroscopy / Q000379:methods* / Q000592:standards; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic / Q000379:methods*; D018579:Patient Selection; D015203:Reproducibility of Results