Safety and efficacy of mangafodipir trisodium (MnDPDP) injection for hepatic MRI in adults: Results of the U.S. Multicenter phase III clinical trials (safety)

Michael P. Federle, Judith L. Chezmar, Daniel L. Rubin, Jeffrey C. Weinreb, Patrick C. Freeny, Richard C. Semelka, Jeffrey J. Brown, Joseph A. Borrello, Joseph K.T. Lee, Robert Mattrey, Abraham H. Dachman, Sanjay Saini, Ben Harmon, Marc Fenstermacher, Retta E. Pelsang, Steven E. Harms, Donald G. Mitchell, Hollis H. Halford, Mark W. Anderson, C. Daniel JohnsonIsaac R. Francis, James G. Bova, Philip J. Kenney, Donald L. Klippenstein, Gregory S. Foster, David A. Turner, Arthur E. Stillman, Rendon C. Nelson, Stuart W. Young, Richard H. Patt, Matthew Rifkin, Steven E. Seltzer, Spencer B. Gay, Ronald O. Robison, Paul F. Sherwin, Rocco Ballerini

Research output: Contribution to journalArticle

49 Citations (Scopus)

Abstract

The short-term1 safety of mangafodipir trisodium (MnDPDP) injection was studied in 546 adults with known or suspected focal liver lesions. An initial contrast-enhanced computed tomography examination was followed by unenhanced magnetic resonance imaging (MRI), injection of MnDPDP (5 μmol/kg), and enhanced MRI. Adverse events were reported for 23% of the patients; most were mild to moderate in intensity, did not require treatment, and were not drug related. The most commonly reported adverse events were nausea (7%) and headache (4%). The incidence of serious adverse events was low (nine events in six patients) and not drug related. Injection-associated discomfort was reported for 69% of the patients, and the most commonly reported discomforts included heat (49%] and flushing (33%). Changes in laboratory values and vital signs were generally transient, were not clinically significant, and did not require treatment. There were no clinically significant short-term risks from exposure to MnDPDP. (C) 2000 Wiley-Liss, Inc.

Original languageEnglish (US)
Pages (from-to)186-197
Number of pages12
JournalJournal of Magnetic Resonance Imaging
Volume12
Issue number1
DOIs
StatePublished - Jul 1 2000

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Phase III Clinical Trials
Magnetic Resonance Imaging
Safety
Injections
Liver
Vital Signs
Pharmaceutical Preparations
Nausea
Headache
Hot Temperature
Tomography
Incidence
Therapeutics
N,N'-bis(pyridoxal-5-phosphate)ethylenediamine-N,N'-diacetic acid

Keywords

  • Adverse events
  • Cirrhosis
  • Contrast media
  • Liver neoplasms
  • Mangafodipir trisodium
  • Manganese
  • MnDPDP
  • MRI
  • Safety
  • Teslascan
  • Toxicity

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

Cite this

Safety and efficacy of mangafodipir trisodium (MnDPDP) injection for hepatic MRI in adults : Results of the U.S. Multicenter phase III clinical trials (safety). / Federle, Michael P.; Chezmar, Judith L.; Rubin, Daniel L.; Weinreb, Jeffrey C.; Freeny, Patrick C.; Semelka, Richard C.; Brown, Jeffrey J.; Borrello, Joseph A.; Lee, Joseph K.T.; Mattrey, Robert; Dachman, Abraham H.; Saini, Sanjay; Harmon, Ben; Fenstermacher, Marc; Pelsang, Retta E.; Harms, Steven E.; Mitchell, Donald G.; Halford, Hollis H.; Anderson, Mark W.; Johnson, C. Daniel; Francis, Isaac R.; Bova, James G.; Kenney, Philip J.; Klippenstein, Donald L.; Foster, Gregory S.; Turner, David A.; Stillman, Arthur E.; Nelson, Rendon C.; Young, Stuart W.; Patt, Richard H.; Rifkin, Matthew; Seltzer, Steven E.; Gay, Spencer B.; Robison, Ronald O.; Sherwin, Paul F.; Ballerini, Rocco.

In: Journal of Magnetic Resonance Imaging, Vol. 12, No. 1, 01.07.2000, p. 186-197.

Research output: Contribution to journalArticle

Federle, MP, Chezmar, JL, Rubin, DL, Weinreb, JC, Freeny, PC, Semelka, RC, Brown, JJ, Borrello, JA, Lee, JKT, Mattrey, R, Dachman, AH, Saini, S, Harmon, B, Fenstermacher, M, Pelsang, RE, Harms, SE, Mitchell, DG, Halford, HH, Anderson, MW, Johnson, CD, Francis, IR, Bova, JG, Kenney, PJ, Klippenstein, DL, Foster, GS, Turner, DA, Stillman, AE, Nelson, RC, Young, SW, Patt, RH, Rifkin, M, Seltzer, SE, Gay, SB, Robison, RO, Sherwin, PF & Ballerini, R 2000, 'Safety and efficacy of mangafodipir trisodium (MnDPDP) injection for hepatic MRI in adults: Results of the U.S. Multicenter phase III clinical trials (safety)', Journal of Magnetic Resonance Imaging, vol. 12, no. 1, pp. 186-197. https://doi.org/10.1002/1522-2586(200007)12:1<186::AID-JMRI21>3.0.CO;2-2
Federle, Michael P. ; Chezmar, Judith L. ; Rubin, Daniel L. ; Weinreb, Jeffrey C. ; Freeny, Patrick C. ; Semelka, Richard C. ; Brown, Jeffrey J. ; Borrello, Joseph A. ; Lee, Joseph K.T. ; Mattrey, Robert ; Dachman, Abraham H. ; Saini, Sanjay ; Harmon, Ben ; Fenstermacher, Marc ; Pelsang, Retta E. ; Harms, Steven E. ; Mitchell, Donald G. ; Halford, Hollis H. ; Anderson, Mark W. ; Johnson, C. Daniel ; Francis, Isaac R. ; Bova, James G. ; Kenney, Philip J. ; Klippenstein, Donald L. ; Foster, Gregory S. ; Turner, David A. ; Stillman, Arthur E. ; Nelson, Rendon C. ; Young, Stuart W. ; Patt, Richard H. ; Rifkin, Matthew ; Seltzer, Steven E. ; Gay, Spencer B. ; Robison, Ronald O. ; Sherwin, Paul F. ; Ballerini, Rocco. / Safety and efficacy of mangafodipir trisodium (MnDPDP) injection for hepatic MRI in adults : Results of the U.S. Multicenter phase III clinical trials (safety). In: Journal of Magnetic Resonance Imaging. 2000 ; Vol. 12, No. 1. pp. 186-197.
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AU - Chezmar, Judith L.

AU - Rubin, Daniel L.

AU - Weinreb, Jeffrey C.

AU - Freeny, Patrick C.

AU - Semelka, Richard C.

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AU - Seltzer, Steven E.

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