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

Michael Federle, Judith Chezmar, Daniel L. Rubin, Jeffrey Weinreb, Patrick Freeny, Udo P. Schmiedl, Jeffrey J. Brown, Joseph A. Borrello, Joseph K.T. Lee, Richard C. Semelka, Robert Mattrey, Abraham H. Dachman, Sanjay Saini, Steven E. Harms, Donald G. Mitchell, Mark W. Anderson, Hollis H. Halford, William F. Bennett, Stuart W. Young, Matthew Rifkin & 4 others Spencer B. Gay, Rocco Ballerini, Paul F. Sherwin, Ronald O. Robison

Research output: Contribution to journalArticle

59 Citations (Scopus)

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 μmol/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. (C) 2000 Wiley-Liss, Inc.

Original languageEnglish (US)
Pages (from-to)689-701
Number of pages13
JournalJournal of Magnetic Resonance Imaging
Volume12
Issue number5
DOIs
StatePublished - Nov 13 2000

Fingerprint

Phase III Clinical Trials
Magnetic Resonance Imaging
Safety
Injections
Liver
Tomography
N,N'-bis(pyridoxal-5-phosphate)ethylenediamine-N,N'-diacetic acid
Intravenous Administration
Contrast Media
Liver Diseases

Keywords

  • Cirrhosis
  • Contrast media
  • Efficacy
  • Liver neoplasms
  • Mangafodipir trisodium
  • Manganese
  • MnDPDP
  • MRI
  • Teslascan

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

Cite this

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. / Federle, Michael; Chezmar, Judith; Rubin, Daniel L.; Weinreb, Jeffrey; Freeny, Patrick; Schmiedl, Udo P.; Brown, Jeffrey J.; Borrello, Joseph A.; Lee, Joseph K.T.; Semelka, Richard C.; Mattrey, Robert; Dachman, Abraham H.; Saini, Sanjay; Harms, Steven E.; Mitchell, Donald G.; Anderson, Mark W.; Halford, Hollis H.; Bennett, William F.; Young, Stuart W.; Rifkin, Matthew; Gay, Spencer B.; Ballerini, Rocco; Sherwin, Paul F.; Robison, Ronald O.

In: Journal of Magnetic Resonance Imaging, Vol. 12, No. 5, 13.11.2000, p. 689-701.

Research output: Contribution to journalArticle

Federle, M, Chezmar, J, Rubin, DL, Weinreb, J, Freeny, P, Schmiedl, UP, Brown, JJ, Borrello, JA, Lee, JKT, Semelka, RC, Mattrey, R, Dachman, AH, Saini, S, Harms, SE, Mitchell, DG, Anderson, MW, Halford, HH, Bennett, WF, Young, SW, Rifkin, M, Gay, SB, Ballerini, R, Sherwin, PF & Robison, RO 2000, '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', Journal of Magnetic Resonance Imaging, vol. 12, no. 5, pp. 689-701. https://doi.org/10.1002/1522-2586(200011)12:5<689::AID-JMRI5>3.0.CO;2-Z
Federle, Michael ; Chezmar, Judith ; Rubin, Daniel L. ; Weinreb, Jeffrey ; Freeny, Patrick ; Schmiedl, Udo P. ; Brown, Jeffrey J. ; Borrello, Joseph A. ; Lee, Joseph K.T. ; Semelka, Richard C. ; Mattrey, Robert ; Dachman, Abraham H. ; Saini, Sanjay ; Harms, Steven E. ; Mitchell, Donald G. ; Anderson, Mark W. ; Halford, Hollis H. ; Bennett, William F. ; Young, Stuart W. ; Rifkin, Matthew ; Gay, Spencer B. ; Ballerini, Rocco ; Sherwin, Paul F. ; Robison, Ronald O. / 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. In: Journal of Magnetic Resonance Imaging. 2000 ; Vol. 12, No. 5. pp. 689-701.
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AU - Schmiedl, Udo P.

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