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

Invest Radiol. 2000 Jul;35(7):412-9. doi: 10.1097/00004424-200007000-00003.


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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Brain / pathology
  • Central Nervous System Diseases / pathology*
  • Contrast Media* / adverse effects
  • Double-Blind Method
  • Female
  • Gadolinium
  • Gadolinium DTPA* / adverse effects
  • Humans
  • Male
  • Middle Aged
  • Organometallic Compounds* / adverse effects
  • Spinal Cord / pathology


  • Contrast Media
  • Organometallic Compounds
  • Gadolinium
  • Gadolinium DTPA
  • gadoversetamide