Advertisement

European Radiology

, Volume 13, Issue 7, pp 1685–1692 | Cite as

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

  • Luis Martí-Bonmatí
  • Amura F. Fog
  • Bart Op de Beeck
  • Pauline Kane
  • Hans Fagertun
Hepatobiliary-Pancreas

Abstract.

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 µmol/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.

Keywords

MR imaging Liver Contrast agents Cirrhosis Mangafodipir trisodium Efficacy studies 

References

  1. 1.
    Elizondo G, Fretz CJ, Stark DD et al. (1991) Preclinical evaluation of Mangafodipir trisodium: new paramagnetic hepatobiliary contrast agent for MR imaging. Radiology 178:73–78CrossRefPubMedGoogle Scholar
  2. 2.
    Wang C, Gordon PB, Hustvedt SO et al. (1997) MR imaging properties and pharmacokinetics of Mangafodipir trisodium in healthy volunteers. Acta Radiol 38:665–676CrossRefPubMedGoogle Scholar
  3. 3.
    Hamm B, Vogl TJ, Branding G, Schnell B, Taupitz M, Wolf KJ, Lissner J (1992) Focal liver lesions: MR imaging with Mn-DPDP initial clinical results in 40 patients. Radiology 182:167–174CrossRefPubMedGoogle Scholar
  4. 4.
    Murakami T, Baron RL, Federle MP et al. (1996) Cirrhosis of the liver: MR imaging with Mangafodipir trisodium (Mn-DPDP). Radiology 198:567–572CrossRefPubMedGoogle Scholar
  5. 5.
    Marti-Bonmati L, Lonjedo E, Poyatos C, Casillas C (1998) MnDDP enhancement characteristics and differentiation between cirrhotic and non-cirrhotic livers. Invest Radiol 33:717–722CrossRefPubMedGoogle Scholar
  6. 6.
    Marchal GM, Ni Y, Yu J, Lodemann KP, Baert AL (1993) Mn-DPDP enhanced MRI in experimental bile duct obstruction. J Comput Assist Tomogr 17:290–296CrossRefPubMedGoogle Scholar
  7. 7.
    Bernardino ME, Young SW, Lee JK, Weinreb JC (1992) Hepatic MR imaging with Mn-DPDP: safety, image quality, and sensitivity. Radiology 183:53–58CrossRefPubMedGoogle Scholar
  8. 8.
    Torres CG, Lundby B, Tufte Sterud A, McGill S, Gordon PB, Strand Bjerknes H (1997) Mangafodipir trisodium for MR imaging of the liver. Results from the European phase III studies. Acta Radiol 38:631–637PubMedGoogle Scholar
  9. 9.
    Bartolozzi C, Donati F, Cioni L, Crocetti L, Lencioni R (2000) Mangafodipir trisodium-enhanced MRI vs dual-phase spiral CT in the detection of hepatocellular carcinoma in cirrhosis. Eur Radiol 10:1697–1702CrossRefPubMedGoogle Scholar
  10. 10.
    Gresti A (1990) Categorical data analysis. Wiley, New YorkGoogle Scholar
  11. 11.
    Murakami T, Baron RL, Peterson MS, Oliver JH, Davis PL, Confer SR, Federle MP (1996) Hepatocellular carcinoma: MR imaging with Mangafodipir trisodium (Mn-DPDP). Radiology 200:69–77CrossRefPubMedGoogle Scholar
  12. 12.
    Federle MP, Chezmar JL, Rubin DL et al. (2000) Safety and efficacy of Mangafodipir trisodium injection for hepatic MRI in adults: results of the U.S. multicenter phase III clinical trials (safety). J Magn Reson Imaging 12:186–197CrossRefPubMedGoogle Scholar
  13. 13.
    Marti-Bonmati L, Torregrosa A, Miguel A, Molla E, Dosda R, Arana E (2001) Safety and efficacy of a bolus administration of Mangafodipir trisodium in MR liver studies. Ninth Scientific Meeting ISMRM and 14th Annual meeting ESMRMBGoogle Scholar
  14. 14.
    Helmberger TK, Laubenberger J, Rummeny E, Jung G, Sievers K, Dohring W, Meurer K, Reiser MF (2002) MRI characteristics in focal hepatic disease before and after administration of MnDPDP: discriminant analysis as a diagnostic tool. Eur Radiol 12:62–70CrossRefPubMedGoogle Scholar

Copyright information

© Springer-Verlag 2003

Authors and Affiliations

  • Luis Martí-Bonmatí
    • 1
  • Amura F. Fog
    • 2
  • Bart Op de Beeck
    • 3
  • Pauline Kane
    • 4
  • Hans Fagertun
    • 5
  1. 1.Department of RadiologyDoctor Peset University HospitalValenciaSpain
  2. 2.Amersham HealthOsloNorway
  3. 3.Department of RadiologyUniversity Hospital of Antwerp, UZAEdegemBelgium
  4. 4.Department of RadiologyKing's College HospitalLondonUK
  5. 5.3S Scandinavian Statistical Services ASNorway

Personalised recommendations