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

Publication ,  Journal Article
Federle, MP; Chezmar, JL; Rubin, DL; Weinreb, JC; Freeny, PC; Semelka, RC; Brown, JJ; Borello, JA; Lee, JK; Mattrey, R; Dachman, AH; Saini, S ...
Published in: J Magn Reson Imaging
July 2000

The short-term 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 micromol/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.

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Published In

J Magn Reson Imaging

DOI

ISSN

1053-1807

Publication Date

July 2000

Volume

12

Issue

1

Start / End Page

186 / 197

Location

United States

Related Subject Headings

  • Vomiting
  • Sensitivity and Specificity
  • Risk Assessment
  • Pyridoxal Phosphate
  • Pregnancy
  • Pain
  • Nuclear Medicine & Medical Imaging
  • Middle Aged
  • Male
  • Magnetic Resonance Imaging
 

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Federle, M. P., Chezmar, J. L., Rubin, D. L., Weinreb, J. C., Freeny, P. C., Semelka, R. C., … Turner, D. A. (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). J Magn Reson Imaging, 12(1), 186–197. https://doi.org/10.1002/1522-2586(200007)12:1<186::aid-jmri21>3.0.co;2-2
Federle, M. P., J. L. Chezmar, D. L. Rubin, J. C. Weinreb, P. C. Freeny, R. C. Semelka, J. J. Brown, et al. “Safety and efficacy of mangafodipir trisodium (MnDPDP) injection for hepatic MRI in adults: results of the U.S. multicenter phase III clinical trials (safety).J Magn Reson Imaging 12, no. 1 (July 2000): 186–97. https://doi.org/10.1002/1522-2586(200007)12:1<186::aid-jmri21>3.0.co;2-2.
Federle MP, Chezmar JL, Rubin DL, Weinreb JC, Freeny PC, Semelka RC, et al. Safety and efficacy of mangafodipir trisodium (MnDPDP) injection for hepatic MRI in adults: results of the U.S. multicenter phase III clinical trials (safety). J Magn Reson Imaging. 2000 Jul;12(1):186–97.
Federle, M. P., et al. “Safety and efficacy of mangafodipir trisodium (MnDPDP) injection for hepatic MRI in adults: results of the U.S. multicenter phase III clinical trials (safety).J Magn Reson Imaging, vol. 12, no. 1, July 2000, pp. 186–97. Pubmed, doi:10.1002/1522-2586(200007)12:1<186::aid-jmri21>3.0.co;2-2.
Federle MP, Chezmar JL, Rubin DL, Weinreb JC, Freeny PC, Semelka RC, Brown JJ, Borello JA, Lee JK, 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. Safety and efficacy of mangafodipir trisodium (MnDPDP) injection for hepatic MRI in adults: results of the U.S. multicenter phase III clinical trials (safety). J Magn Reson Imaging. 2000 Jul;12(1):186–197.
Journal cover image

Published In

J Magn Reson Imaging

DOI

ISSN

1053-1807

Publication Date

July 2000

Volume

12

Issue

1

Start / End Page

186 / 197

Location

United States

Related Subject Headings

  • Vomiting
  • Sensitivity and Specificity
  • Risk Assessment
  • Pyridoxal Phosphate
  • Pregnancy
  • Pain
  • Nuclear Medicine & Medical Imaging
  • Middle Aged
  • Male
  • Magnetic Resonance Imaging