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 Johnson; Isaac 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

doi:10.1002/1522-2586(200007)12:1<186::AID-JMRI21>3.0.CO;2-2

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

Diagnostic Radiology

Research output: Contribution to journal › Article › peer-review

52 Scopus citations

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 language	English (US)
Pages (from-to)	186-197
Number of pages	12
Journal	Journal of Magnetic Resonance Imaging
Volume	12
Issue number	1
DOIs	https://doi.org/10.1002/1522-2586(200007)12:1<186::AID-JMRI21>3.0.CO;2-2
State	Published - Jul 2000

Keywords

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

ASJC Scopus subject areas

Radiology Nuclear Medicine and imaging

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10.1002/1522-2586(200007)12:1<186::AID-JMRI21>3.0.CO;2-2

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Federle, M. P., Chezmar, J. L., Rubin, D. L., Weinreb, J. C., Freeny, P. C., Semelka, R. C., Brown, J. J., Borrello, J. A., Lee, J. K. T., Mattrey, R., Dachman, A. H., Saini, S., Harmon, B., Fenstermacher, M., Pelsang, R. E., Harms, S. E., Mitchell, D. G., Halford, H. H., Anderson, M. W., ... 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, 12(1), 186-197. https://doi.org/10.1002/1522-2586(200007)12:1<186::AID-JMRI21>3.0.CO;2-2

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. et al.

In: Journal of Magnetic Resonance Imaging, Vol. 12, No. 1, 07.2000, p. 186-197.

Research output: Contribution to journal › Article › peer-review

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

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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.",

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

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T2 - Results of the U.S. Multicenter phase III clinical trials (safety)

AU - Federle, Michael P.

AU - Chezmar, Judith L.

AU - Rubin, Daniel L.

AU - Weinreb, Jeffrey C.

AU - Freeny, Patrick C.

AU - Semelka, Richard C.

AU - Brown, Jeffrey J.

AU - Borrello, Joseph A.

AU - Lee, Joseph K.T.

AU - Mattrey, Robert

AU - Dachman, Abraham H.

AU - Saini, Sanjay

AU - Harmon, Ben

AU - Fenstermacher, Marc

AU - Pelsang, Retta E.

AU - Harms, Steven E.

AU - Mitchell, Donald G.

AU - Halford, Hollis H.

AU - Anderson, Mark W.

AU - Johnson, C. Daniel

AU - Francis, Isaac R.

AU - Bova, James G.

AU - Kenney, Philip J.

AU - Klippenstein, Donald L.

AU - Foster, Gregory S.

AU - Turner, David A.

AU - Stillman, Arthur E.

AU - Nelson, Rendon C.

AU - Young, Stuart W.

AU - Patt, Richard H.

AU - Rifkin, Matthew

AU - Seltzer, Steven E.

AU - Gay, Spencer B.

AU - Robison, Ronald O.

AU - Sherwin, Paul F.

AU - Ballerini, Rocco

PY - 2000/7

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N2 - 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.

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KW - Liver neoplasms

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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)

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Keywords

ASJC Scopus subject areas

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