title: Randomized multicentre trial of gadoxetic acid-enhanced MRI versus conventional MRI or CT in the staging of colorectal cancer liver metastases.
abstract: BACKGROUND
  This multicentre international randomized trial compared the impact of gadoxetic acid-enhanced magnetic resonance imaging (MRI), MRI with extracellular contrast medium (ECCM-MRI) and contrast-enhanced computed tomography (CE-CT) as a first-line imaging method in patients with suspected colorectal cancer liver metastases (CRCLM).
  
  
  METHODS
  Between October 2008 and September 2010, patients with suspected CRCLM were randomized to one of the three imaging modalities. The primary endpoint was the proportion of patients for whom further imaging after initial imaging was required for a confident diagnosis. Secondary variables included confidence in the therapeutic decision, intraoperative deviations from the initial imaging-based surgical plan as a result of additional operative findings, and diagnostic efficacy of the imaging modalities versus intraoperative and pathological extent of the disease.
  
  
  RESULTS
  A total of 360 patients were enrolled. Efficacy was analysed in 342 patients (118, 112 and 112 with gadoxetic acid-enhanced MRI, ECCM-MRI and CE-CT respectively as the initial imaging procedure). Further imaging was required in 0 of 118, 19 (17.0 per cent) of 112 and 44 (39.3 per cent) of 112 patients respectively (P < 0.001). Diagnostic confidence was high or very high in 98.3 per cent of patients for gadoxetic acid-enhanced MRI, 85.7 per cent for ECCM-MRI and 65.2 per cent for CE-CT. Surgical plans were changed during surgery in 28, 32 and 47 per cent of patients in the respective groups.
  
  
  CONCLUSIONS
  The diagnostic performance of gadoxetic acid-enhanced MRI was better than that of CE-CT and ECCM-MRI as the initial imaging modality. No further imaging was needed in the gadoxetic acid-enhanced MRI group and comparison of diagnostic efficacy parameters demonstrated the diagnostic superiority of gadoxetic acid-enhanced MRI.
  
  
  BACKGROUND
  NCT00764621(http://clinicaltrials.gov); EudraCT number: 2008-000583-16 (https://eudract.ema.europa.eu/).
authors.affiliation: Institute of Clinical Radiology, University Hospital Munich - Grosshadern, Munich, and; Clinic of Radiology and Nuclear Medicine, University Hospital Basle, Basle, Switzerland.
authors.forename: C J
authors.initials: CJ
authors.lastname: Zech
authors.forename: P
authors.initials: P
authors.lastname: Korpraphong
authors.forename: A
authors.initials: A
authors.lastname: Huppertz
authors.forename: T
authors.initials: T
authors.lastname: Denecke
authors.forename: M J
authors.initials: MJ
authors.lastname: Kim
authors.forename: W
authors.initials: W
authors.lastname: Tanomkiat
authors.forename: E
authors.initials: E
authors.lastname: Jonas
authors.forename: A
authors.initials: A
authors.lastname: Ba-Ssalamah
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015179:Colorectal Neoplasms; D003287:Contrast Media; D005260:Female; D019786:Gadolinium DTPA; D006801:Humans; D008113:Liver Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology* / Q000556:secondary / Q000601:surgery; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging / Q000379:methods; D010347:Patient Care Planning; D012680:Sensitivity and Specificity; D014057:Tomography, X-Ray Computed / Q000379:methods; D016896:Treatment Outcome
chemical_list: D003287:Contrast Media; C073590:gadolinium ethoxybenzyl DTPA; D019786:Gadolinium DTPA