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Magnetic resonance imaging in patients with central nervous system pathology: a comparison of OptiMARK (Gd-DTPA-BMEA) and Magnevist (Gd-DTPA)

Publication Type:

Journal Article

Authors:

Grossman, R. I.; Rubin, D. L.; Hunter, G.; Haughton, V. M.; Lee, D.; Sze, G.; Kuhn, M. J.; Maravilla, K.; Tu, R.; Heindel, W.; Wippold, F. J., 2nd; Leeds, N.; Zelch, J.; Jinkins, J. R.; Grodd, W.; Truwit, C.; Kanal, E.; Provenzale, J. M.; Ramsey, R.; Simon, J.; Brunberg, J. A.; Stevens, G. R.; Kristy, R. M.

Source:

Invest Radiol, Volume 35, Number 7, p.412-9 (2000)

Accession Number:

10901102

Keywords:

*Contrast Media/adverse effects, Adult, Aged, Brain/pathology, Central Nervous System Diseases/*pathology, Double-Blind Method, Female, Gadolinium DTPA/adverse effects/*diagnostic use, Gadolinium/diagnostic use, Human, Male, Middle Age, Organometallic Compounds/adverse effects/*diagnostic use, Spinal Cord/pathology

Abstract:

RATIONALE AND OBJECTIVES: The objective of the two pivotal phase 3 studies was to evaluate the safety and efficacy of OptiMARK (Gd-DTPA-bis(methoxyethylamide) [Gd-DTPA-BMEA]) compared with Magnevist (Gd-DTPA) in magnetic resonance imaging of the central nervous system. METHODS: Two multicenter, randomized, double-blind, parallel group studies were conducted in 395 patients with known or suspected central nervous system pathology. Subjects were randomized to receive a single 0.1 mmol/kg intravenous injection of either Gd-DTPA-BMEA or Gd-DTPA. The safety of Gd-DTPA-BMEA and Gd-DTPA was monitored for up to 72 hours after study drug administration. Precontrast and postcontrast administration magnetic resonance scans were acquired using identical imaging planes and techniques. RESULTS: No deaths or unexpected adverse events were reported in either group. A comparison of adverse events by intensity and relation demonstrated no statistically significant differences between the two groups. Gd-DTPA-BMEA and Gd-DTPA were equivalent with respect to confidence in diagnosis, conspicuity, and border delineation. CONCLUSIONS: Gd-DTPA-BMEA and Gd-DTPA demonstrated comparable efficacy profiles, and the safety profiles were considered similar.