title: Multicenter, double-blind, randomized, intraindividual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine for Breast MR imaging (DETECT Trial).
abstract: OBJECTIVE
  To intraindividually compare 0.1 mmol/kg doses of gadobenate dimeglumine and gadopentetate dimeglumine for contrast material-enhanced breast magnetic resonance (MR) imaging by using a prospective, multicenter double-blind, randomized protocol.
  
  
  METHODS
  Institutional review board approval and patient informed consent were obtained. One hundred sixty-two women (mean age, 52.8 years ± 12.3 [standard deviation]) enrolled at 17 sites in Europe and China between July 2007 and May 2009 underwent at least one breast MR imaging examination at 1.5 T by using three-dimensional spoiled gradient-echo sequences. Of these, 151 women received both contrast agents in randomized order in otherwise identical examinations separated by more than 2 but less than 7 days. Images, acquired at 2-minute or shorter intervals after contrast agent injection, were evaluated independently by three blinded radiologists unaffiliated with enrollment centers. Histopathologic confirmation was available for all malignant lesions (n = 144), while benign lesions were confirmed either by using histopathologic examination (n = 52) or by at least 12-month diagnostic follow-up (n = 20) with mammography and/or ultrasonography. Determinations of malignant lesion detection rates and diagnostic performance (sensitivity, specificity, accuracy, positive predictive value [PPV], and negative predictive value [NPV]) were performed and compared (McNemar and Wald tests). A full safety assessment was performed.
  
  
  RESULTS
  Significant superiority for gadobenate dimeglumine was noted by readers 1, 2, and 3 for malignant lesion detection rate (91.7%, 93.1%, 94.4% vs 79.9%, 80.6%, 83.3%, respectively; P ≤ .0003). Readers 1, 2, and 3 reported significantly superior diagnostic performance (sensitivity, specificity, and accuracy) for breast cancer detection with gadobenate dimeglumine (91.1%, 94.5%, 95.2% vs 81.2%, 82.6%, 84.6%; 99.0%, 98.2%, 96.9% vs 97.8%, 96.9%, 93.8%; 98.2%, 97.8%, 96.7% vs 96.1%, 95.4%, 92.8%, respectively; P ≤ .0094) and significantly superior PPV (91.1%, 85.2%, 77.2% vs 80.7%, 75.5%, 60.9%, respectively; P ≤ .0002) and NPV (99.0%, 99.4%, 99.4% vs 97.8%, 98.0%, 98.1%, respectively; P ≤ .0003). No safety concerns were noted with either agent.
  
  
  CONCLUSIONS
  Gadobenate dimeglumine is superior to gadopentetate dimeglumine for breast cancer diagnosis. © RSNA, 2010 Clinical trial registration no. NCT00486473 (http://www.clinicaltrials.gov/).
  
  
  BACKGROUND
  http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.10100968/-/DC1.
authors.affiliation: Department of Diagnostic Imaging, Institute for Cancer Research and Treatment, Istituto per la Ricerca e la Cura del Cancro, Fondazione piemontese per l’oncologia, Candiolo, Turin, Italy. laura.martincich@ircc.it
authors.forename: Laura
authors.initials: L
authors.lastname: Martincich
authors.forename: Matthieu
authors.initials: M
authors.lastname: Faivre-Pierret
authors.forename: Christian M
authors.initials: CM
authors.lastname: Zechmann
authors.forename: Stefano
authors.initials: S
authors.lastname: Corcione
authors.forename: Harrie C M
authors.initials: HC
authors.lastname: van den Bosch
authors.forename: Wei-Jun
authors.initials: WJ
authors.lastname: Peng
authors.forename: Antonella
authors.initials: A
authors.lastname: Petrillo
authors.forename: Katja C
authors.initials: KC
authors.lastname: Siegmann
authors.forename: Johannes T
authors.initials: JT
authors.lastname: Heverhagen
authors.forename: Pietro
authors.initials: P
authors.lastname: Panizza
authors.forename: Hans-Björn
authors.initials: HB
authors.lastname: Gehl
authors.forename: Felix
authors.initials: F
authors.lastname: Diekmann
authors.forename: Federica
authors.initials: F
authors.lastname: Pediconi
authors.forename: Lin
authors.initials: L
authors.lastname: Ma
authors.forename: Fiona J
authors.initials: FJ
authors.lastname: Gilbert
authors.forename: Francesco
authors.initials: F
authors.lastname: Sardanelli
authors.forename: Paolo
authors.initials: P
authors.lastname: Belli
authors.forename: Marco
authors.initials: M
authors.lastname: Salvatore
authors.forename: Karl-Friedrich
authors.initials: KF
authors.lastname: Kreitner
authors.forename: Claudia M
authors.initials: CM
authors.lastname: Weiss
authors.forename: Chiara
authors.initials: C
authors.lastname: Zuiani
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000473:pathology; D016009:Chi-Square Distribution; D002681:China; D003287:Contrast Media; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D019786:Gadolinium DTPA; D006801:Humans; D007090:Image Interpretation, Computer-Assisted; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008536:Meglumine / Q000031:analogs & derivatives*; D008875:Middle Aged; D009942:Organometallic Compounds; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012680:Sensitivity and Specificity
chemical_list: D003287:Contrast Media; D009942:Organometallic Compounds; C064572:gadobenic acid; D008536:Meglumine; D019786:Gadolinium DTPA