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, J 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 F.; Dachman, Abraham H.; Saini, Sanjay; Harmon, Ben H.; Fenstermacher, Marc J.; Pelsang, Retta E.; Harms, Steven E.; Mitchell, Donald G.; Halford, Hollis H.; Anderson, Mark; Johnson, Charles D.; Francis, Isaac R.; Bova, James G.; Kenney, Philip J.; Klippenstein, Donald; Foster, Gregory S.; Turner, David A.; Stillman, Arthur E.; Nelson, Rendon C.; Young, Stuart W.; Patt, Richard H.; Rifkin, Matthew D.; Seltzer, Steven E.; Robison, Ronald O.; Sherwin, Paul; Ballerini, Rocco

doi:10.1002/1522-2586(200007)12:1<186::aid-jmri21>3.0.co;2-2

Cited by 70 publications

(43 citation statements)

References 70 publications

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“…The most frequent adverse events associated with the administration of Mangafodipir trisodium are nausea, vomiting, headache, and pruritus [8,12]. The injectionassociated discomforts of heat and flushing are most common with higher injection rates and are probably related to peripheral vasodilatation [8,12].…”

Section: Discussionmentioning

confidence: 99%

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Safety and efficacy of Mangafodipir trisodium in patients with liver lesions and cirrhosis

Martí‐Bonmatí

Fog²,

Beeck

et al. 2003

Eur Radiol

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Mangafodipir trisodium (Mn-DPDP, Teslascan) is a well-tolerated liver contrast agent. Although the enhancement characteristics of the cirrhotic liver after Mangafodipir trisodium administration have been studied, at present there is no published data on the impact that cirrhosis might have on the safety and efficacy profiles of this agent. Our objective is to evaluate by means of a retrospective comparison the safety and efficacy of Mangafodipir trisodium in patients with underlying cirrhosis who were examined for suspicion of focal liver lesions. A total of 923 patients received Mangafodipir trisodium (5 micromol/kg) in 11 prospective randomized European clinical trials. Adverse events and discomfort were recorded and graded in all patients. The efficacy analyses were performed on the subsets consisting of 617 patients with independent lesion counts (detection), and on the subset with 399 patients with independent and onsite final lesion diagnosis (characterization). Of the 399 patients, 149 had histologic confirmation. One hundred eighty of 923 patients (19.5%) had cirrhosis. There were no main differences between cirrhotic and non-cirrhotic patients. Adverse events were observed in 64 patients (6.9%), 6.7% in the cirrhotic group and 7.0% in the non-cirrhotic group, a non-significant difference. Adverse events in most patients were mild or moderate. The presence and intensity of the events did not differ between groups. Discomfort was recorded in 79 patients (8.6%), equally distributed in cirrhotic (6.1%) and non-cirrhotic (9.2%) patients. Regarding lesion count, significantly more lesions were found in the post- than in the precontrast images in both the cirrhotic and non-cirrhotic groups ( p<0.0001). This increase was not influenced by the presence of liver cirrhosis ( p=0.94). Lesion characterization was significantly improved in cirrhotic patients after administration of Mangafodipir trisodium ( p=0.002) but not in non-cirrhotic patients ( p=0.13). Mangafodipir trisodium is a safe and well-tolerated useful contrast agent in patients with cirrhosis.

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Section: Discussionmentioning

confidence: 99%

“…The injectionassociated discomforts of heat and flushing are most common with higher injection rates and are probably related to peripheral vasodilatation [8,12].…”

Section: Discussionmentioning

confidence: 99%

Safety and efficacy of Mangafodipir trisodium in patients with liver lesions and cirrhosis

Martí‐Bonmatí

Fog²,

Beeck

et al. 2003

Eur Radiol

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“…Manganese dipyridoxaldiphosphate (MnDPDP), an FDA approved contrast agent used for imaging of the liver, has been used for negative enhancement of hepatic abnormalities. 35 Furthermore, MnDPDP has been successfully utilized for imaging cardiac ischemia. 34,[36][37][38] It is interesting to note that much of the Mn 2þ in MnDPDP comes off the chelate slowly after administration, 39 which implies some of the tissue enhancement detected with MnDPDP was due to Mn 2þ .…”

Section: Manganese Is An Intracellular Contrast Agentmentioning

confidence: 99%

Manganese‐enhanced magnetic resonance imaging (MEMRI): methodological and practical considerations

et al. 2004

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Manganese-enhanced MRI (MEMRI) is being increasingly used for MRI in animals due to the unique T 1 contrast that is sensitive to a number of biological processes. Three specific uses of MEMRI have been demonstrated: to visualize activity in the brain and the heart; to trace neuronal specific connections in the brain; and to enhance the brain cytoarchitecture after a systemic dose. Based on an ever-growing number of applications, MEMRI is proving useful as a new molecular imaging method to visualize functional neural circuits and anatomy as well as function in the brain in vivo. Paramount to the successful application of MEMRI is the ability to deliver Mn 2þ to the site of interest at an appropriate dose and in a time-efficient manner. A major drawback to the use of Mn 2þ as a contrast agent is its cellular toxicity. Therefore, it is critical to use as low a dose as possible. In the present work the different approaches to MEMRI are reviewed from a practical standpoint. Emphasis is given to the experimental methodology of how to achieve significant, yet safe, amounts of Mn 2þ to the target areas of interest.

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“…Mangafodipir trisodium (Teslascan; Amersham Health, Princeton, NJ), a safe U.S. Food and Drug Administration-approved hepatobiliary MR imaging contrast agent (18), is excreted primarily by way of the biliary system and can be used as a T1-weighted MR imaging biliary contrast agent because of the T1 shortening caused by the manganese metal ion. The use of this agent for the examination of living liver donor candidates, although promising, has been limited to a few small studies (13,15,16).…”

mentioning

confidence: 99%

Defining Intrahepatic Biliary Anatomy in Living Liver Transplant Donor Candidates at Mangafodipir Trisodium–enhanced MR Cholangiography versus Conventional T2-weighted MR Cholangiography

et al. 2004

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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)

Cited by 70 publications

References 70 publications

Safety and efficacy of Mangafodipir trisodium in patients with liver lesions and cirrhosis

Safety and efficacy of Mangafodipir trisodium in patients with liver lesions and cirrhosis

Manganese‐enhanced magnetic resonance imaging (MEMRI): methodological and practical considerations

Defining Intrahepatic Biliary Anatomy in Living Liver Transplant Donor Candidates at Mangafodipir Trisodium–enhanced MR Cholangiography versus Conventional T2-weighted MR Cholangiography

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