Publications [#132104] of James M Provenzale

Papers Published

1. RI Grossman, DL Rubin, G Hunter, VM Haughton, D Lee, G Sze, MJ Kuhn, K Maravilla, R Tu, W Heindel, FJ Wippold, N Leeds, J Zelch, JR Jinkins, W Grodd, C Truwit, E Kanal, JM Provenzale, R Ramsey, J Simon, JA Brunberg, GR Stevens, RM Kristy, Magnetic resonance imaging in patients with central nervous system pathology: a comparison of OptiMARK (Gd-DTPA-BMEA) and Magnevist (Gd-DTPA)., Investigative radiology, UNITED STATES, vol. 35 no. 7 (July, 2000), pp. 412-9, ISSN 0020-9996
   (last updated on 2007/02/06)

   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.

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