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A multicenter, randomized, double-blind study to evaluate the safety, tolerability, and efficacy of OptiMARK (gadoversetamide injection) compared with Magnevist (gadopentetate dimeglumine) in patients with liver pathology: results of a Phase III clinical trial.

Publication ,  Journal Article
Rubin, DL; Desser, TS; Semelka, R; Brown, J; Nghiem, HV; Stevens, WR; Bluemke, D; Nelson, R; Fultz, P; Reimer, P; Ho, V; Kristy, RM; Pierro, JA
Published in: J Magn Reson Imaging
February 1999

The purpose of this study was to evaluate the safety and efficacy of OptiMARK (gadoversetamide injection) compared with Magnevist (gadopentetate dimeglumine) in hepatic MRI of patients with suspected liver pathology. A Phase III, multicenter, randomized, double-blind, parallel group study was performed in adults with suspected liver pathology. All patients underwent contrast-enhanced computed tomography within 3 weeks prior to magnetic resonance scanning. Ninety-nine patients received OptiMARK, and 94 patients received Magnevist at a dose of 0.1 mmol/kg. Precontrast T1- and T2-weighted spin-echo imaging and T1-weighted gradient-echo imaging were performed, followed by T1-weighted gradient-echo imaging at 15-20 seconds, 1 minute, and 5 minutes after intravenous contrast injection. Three primary efficacy endpoints (confidence in lesion diagnosis, level of conspicuity, and lesion border delineation) were evaluated on the precontrast image set and compared with the pre plus postcontrast image set. Vital signs, physical examination, electrocardiograms (ECGs), and laboratory parameters (chemistry, hematology, and urinalysis) were measured at various time points. Adverse events were recorded. The study design and statistical analyses were chosen to demonstrate presumed equivalence of OptiMARK and Magnevist. There were no statistically significant differences in efficacy between OptiMARK and Magnevist as assessed by either blinded readers or the on-site principal investigators. No serious or unexpected adverse events were noted. Of the 193 patients receiving contrast media, 82 experienced a total of 154 adverse events. Thirty-three (21.4%) of these 154 adverse events were felt by the on-site investigators to be probably related to either study agent: 15 events in 9 patients in the OptiMARK group, and 18 events in 13 patients in the Magnevist group. Headache was the most common adverse event, occurring in 10.1% of the OptiMARK patients and 12.8% of the Magnevist patients. No clinically relevant trends were observed in any laboratory parameter or ECG findings in either treatment group. The results demonstrate the safety, efficacy, and equivalence of OptiMARK and Magnevist at a dose of 0.1 mmol/kg in hepatic magnetic resonance imaging of patients with suspected liver pathology.

Duke Scholars

Published In

J Magn Reson Imaging

DOI

ISSN

1053-1807

Publication Date

February 1999

Volume

9

Issue

2

Start / End Page

240 / 250

Location

United States

Related Subject Headings

  • Safety
  • Organometallic Compounds
  • Nuclear Medicine & Medical Imaging
  • Middle Aged
  • Male
  • Magnetic Resonance Imaging
  • Liver Diseases
  • Liver
  • Injections, Intravenous
  • Humans
 

Citation

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Rubin, D. L., Desser, T. S., Semelka, R., Brown, J., Nghiem, H. V., Stevens, W. R., … Pierro, J. A. (1999). A multicenter, randomized, double-blind study to evaluate the safety, tolerability, and efficacy of OptiMARK (gadoversetamide injection) compared with Magnevist (gadopentetate dimeglumine) in patients with liver pathology: results of a Phase III clinical trial. J Magn Reson Imaging, 9(2), 240–250. https://doi.org/10.1002/(sici)1522-2586(199902)9:2<240::aid-jmri14>3.0.co;2-#
Rubin, D. L., T. S. Desser, R. Semelka, J. Brown, H. V. Nghiem, W. R. Stevens, D. Bluemke, et al. “A multicenter, randomized, double-blind study to evaluate the safety, tolerability, and efficacy of OptiMARK (gadoversetamide injection) compared with Magnevist (gadopentetate dimeglumine) in patients with liver pathology: results of a Phase III clinical trial.J Magn Reson Imaging 9, no. 2 (February 1999): 240–50. https://doi.org/10.1002/(sici)1522-2586(199902)9:2<240::aid-jmri14>3.0.co;2-#.
Rubin DL, Desser TS, Semelka R, Brown J, Nghiem HV, Stevens WR, Bluemke D, Nelson R, Fultz P, Reimer P, Ho V, Kristy RM, Pierro JA. A multicenter, randomized, double-blind study to evaluate the safety, tolerability, and efficacy of OptiMARK (gadoversetamide injection) compared with Magnevist (gadopentetate dimeglumine) in patients with liver pathology: results of a Phase III clinical trial. J Magn Reson Imaging. 1999 Feb;9(2):240–250.
Journal cover image

Published In

J Magn Reson Imaging

DOI

ISSN

1053-1807

Publication Date

February 1999

Volume

9

Issue

2

Start / End Page

240 / 250

Location

United States

Related Subject Headings

  • Safety
  • Organometallic Compounds
  • Nuclear Medicine & Medical Imaging
  • Middle Aged
  • Male
  • Magnetic Resonance Imaging
  • Liver Diseases
  • Liver
  • Injections, Intravenous
  • Humans