title: Efficacy and safety of mangafodipir trisodium (MnDPDP) injection for hepatic MRI in adults: results of the U.S. Multicenter phase III clinical trials. Efficacy of early imaging.
abstract: The efficacy of contrast-enhanced magnetic resonance imaging (MRI) for detecting and characterizing, or excluding, hepatic masses was assessed in 404 patients, following the intravenous administration of mangafodipir trisodium (MnDPDP) injection, a hepatic MRI contrast agent. An initial contrast-enhanced computed tomography (CT) examination was followed by unenhanced MRI, injection of MnDPDP (5 micromol/kg IV), and enhanced MRI at 15 minutes post injection. Agreement of the radiologic diagnoses with the patients' final diagnoses was higher for enhanced MRI and for the combined unenhanced and enhanced MRI evaluations than for unenhanced MRI alone or enhanced CT using the clinical diagnosis as the gold standard. Mangafodipir-enhanced MRI uniquely provided additional diagnostic information in 48% of the patients, and patient management was consequently altered in 6% of the patients. MnDPDP-enhanced MRI was comparable or superior to unenhanced MRI and enhanced CT for the detection, classification, and diagnosis of focal liver lesions in patients with known or suspected focal liver disease.
authors.affiliation: Department of Radiology, Presbyterian University Hospital, Pittsburgh, Pennsylvania 15213, USA.
authors.forename: M
authors.initials: M
authors.lastname: Federle
authors.forename: J
authors.initials: J
authors.lastname: Chezmar
authors.forename: D L
authors.initials: DL
authors.lastname: Rubin
authors.forename: J
authors.initials: J
authors.lastname: Weinreb
authors.forename: P
authors.initials: P
authors.lastname: Freeny
authors.forename: U P
authors.initials: UP
authors.lastname: Schmiedl
authors.forename: J J
authors.initials: JJ
authors.lastname: Brown
authors.forename: J A
authors.initials: JA
authors.lastname: Borrello
authors.forename: J K
authors.initials: JK
authors.lastname: Lee
authors.forename: R C
authors.initials: RC
authors.lastname: Semelka
authors.forename: R
authors.initials: R
authors.lastname: Mattrey
authors.forename: A H
authors.initials: AH
authors.lastname: Dachman
authors.forename: S
authors.initials: S
authors.lastname: Saini
authors.forename: S E
authors.initials: SE
authors.lastname: Harms
authors.forename: D G
authors.initials: DG
authors.lastname: Mitchell
authors.forename: M W
authors.initials: MW
authors.lastname: Anderson
authors.forename: H H
authors.initials: HH
authors.lastname: Halford
authors.forename: W F
authors.initials: WF
authors.lastname: Bennett
authors.forename: S W
authors.initials: SW
authors.lastname: Young
authors.forename: M
authors.initials: M
authors.lastname: Rifkin
authors.forename: S B
authors.initials: SB
authors.lastname: Gay
authors.forename: R
authors.initials: R
authors.lastname: Ballerini
authors.forename: P F
authors.initials: PF
authors.lastname: Sherwin
authors.forename: R O
authors.initials: RO
authors.lastname: Robison
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003287:Contrast Media; D003937:Diagnosis, Differential; D004492:Edetic Acid / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D007089:Image Enhancement; D007275:Injections, Intravenous; D008103:Liver Cirrhosis / Q000175:diagnosis*; D008113:Liver Neoplasms / Q000175:diagnosis*; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011732:Pyridoxal Phosphate / Q000009:adverse effects / Q000031:analogs & derivatives*; D012680:Sensitivity and Specificity
chemical_list: D003287:Contrast Media; D011732:Pyridoxal Phosphate; D004492:Edetic Acid; C060076:N,N'-bis(pyridoxal-5-phosphate)ethylenediamine-N,N'-diacetic acid