title: Focal liver lesions: evaluation of the efficacy of gadobenate dimeglumine in MR imaging--a multicenter phase III clinical study.
abstract: OBJECTIVE
  To evaluate gadobenate dimeglumine (Gd-BOPTA) for dynamic and delayed magnetic resonance (MR) imaging of focal liver lesions.
  
  
  METHODS
  In 126 of 214 patients, MR imaging was performed before Gd-BOPTA administration, immediately after bolus administration of a 0.05- mmol/kg dose of Gd-BOPTA, and 60-120 minutes after an additional intravenously infused 0.05-mmol/kg dose. In 88 patients, imaging was performed before and 60-120 minutes after a single, intravenously infused 0.1-mmol/kg dose. T1- and T2-weighted spin-echo and T1-weighted gradient-echo images were acquired. On-site and blinded off-site reviewers prospectively evaluated all images. Intraoperative ultrasonography, computed tomography (CT) during arterial portography, and/or CT with iodized oil served as the reference methods in 110 patients.
  
  
  RESULTS
  Significantly more lesions were detected on combined pre- and postcontrast images compared with on precontrast images alone (P <. 01). All reviewers reported a decreased mean size of the smallest detected lesion and improved lesion conspicuity on postcontrast images. All on-site reviewers and two off-site reviewers reported increased overall diagnostic confidence (P <.01). Additional lesion characterization information was provided on up to 109 (59%) of 184 delayed images and for up to 50 (42%) of 118 patients in whom dynamic images were assessed. Gd-BOPTA would have helped change the diagnosis in 99 (47%) of 209 cases and affected patient treatment in 408 (23%) of 209 cases.
  
  
  CONCLUSIONS
  Gd-BOPTA increases liver lesion conspicuity and detectability and aids in the characterization of lesions.
authors.affiliation: Institute for Radiodiagnostics, Medizinische Fakultät, Humboldt-Universität, Berlin, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Petersein
authors.forename: A
authors.initials: A
authors.lastname: Spinazzi
authors.forename: A
authors.initials: A
authors.lastname: Giovagnoni
authors.forename: P
authors.initials: P
authors.lastname: Soyer
authors.forename: F
authors.initials: F
authors.lastname: Terrier
authors.forename: R
authors.initials: R
authors.lastname: Lencioni
authors.forename: C
authors.initials: C
authors.lastname: Bartolozzi
authors.forename: L
authors.initials: L
authors.lastname: Grazioli
authors.forename: A
authors.initials: A
authors.lastname: Chiesa
authors.forename: R
authors.initials: R
authors.lastname: Manfredi
authors.forename: P
authors.initials: P
authors.lastname: Marano
authors.forename: E L
authors.initials: EL
authors.lastname: Van Persijn Van Meerten
authors.forename: J L
authors.initials: JL
authors.lastname: Bloem
authors.forename: C
authors.initials: C
authors.lastname: Petre
authors.forename: G
authors.initials: G
authors.lastname: Marchal
authors.forename: A
authors.initials: A
authors.lastname: Greco
authors.forename: M T
authors.initials: MT
authors.lastname: McNamara
authors.forename: A
authors.initials: A
authors.lastname: Heuck
authors.forename: M
authors.initials: M
authors.lastname: Reiser
authors.forename: M
authors.initials: M
authors.lastname: Laniado
authors.forename: C
authors.initials: C
authors.lastname: Claussen
authors.forename: H E
authors.initials: HE
authors.lastname: Daldrup
authors.forename: E
authors.initials: E
authors.lastname: Rummeny
authors.forename: M A
authors.initials: MA
authors.lastname: Kirchin
authors.forename: G
authors.initials: G
authors.lastname: Pirovano
authors.forename: B
authors.initials: B
authors.lastname: Hamm
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003287:Contrast Media / Q000008:administration & dosage; D005060:Europe; D005260:Female; D005682:Gadolinium / Q000008:administration & dosage; D006801:Humans; D008099:Liver / Q000473:pathology*; D008113:Liver Neoplasms / Q000175:diagnosis*; D008279:Magnetic Resonance Imaging / Q000295:instrumentation / Q000379:methods* / Q000706:statistics & numerical data; D008297:Male; D008536:Meglumine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage; D011446:Prospective Studies; D012680:Sensitivity and Specificity
chemical_list: D003287:Contrast Media; D009942:Organometallic Compounds; C064572:gadobenic acid; D008536:Meglumine; D005682:Gadolinium