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

Robert I. Grossman, Daniel L. Rubin, George Hunter, Victor M. Haughton, Donald Lee, Gordon Sze, Matthew J. Kühn, Kenneth Maravilla, T. U. Raymond, Walter Heindel, Franz J. Wippold, Norman Leeds, James Zelch, J. Randy Jinkins, Wolfgang Grodd, Charles Truwit, Emanuel Kanal, James M. Provenzale, Ruth Ramsey, Jack SimonJames A Brunberg, Gary R. Stevens, Rita M. Kristy

Research output: Contribution to journalArticle

29 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)412-419
Number of pages8
JournalInvestigative Radiology
Volume35
Issue number7
DOIs
StatePublished - Jul 2000

Fingerprint

Gadolinium DTPA
Central Nervous System
Magnetic Resonance Imaging
Pathology
Safety
DTPA bis(methoxyethylamide)
gadoversetamide
Intravenous Injections
Magnetic Resonance Spectroscopy

Keywords

  • Central nervous system pathology
  • Contrast agents
  • Gadolinium
  • Lesions
  • Magnetic resonance imaging

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Radiological and Ultrasound Technology

Cite this

Magnetic resonance imaging in patients with central nervous system pathology : A comparison of OptiMARK (Gd-DTPA-BMEA) and Magnevist (Gd-DTPA). / Grossman, Robert I.; Rubin, Daniel L.; Hunter, George; Haughton, Victor M.; Lee, Donald; Sze, Gordon; Kühn, Matthew J.; Maravilla, Kenneth; Raymond, T. U.; Heindel, Walter; Wippold, Franz J.; Leeds, Norman; Zelch, James; Jinkins, J. Randy; Grodd, Wolfgang; Truwit, Charles; Kanal, Emanuel; Provenzale, James M.; Ramsey, Ruth; Simon, Jack; Brunberg, James A; Stevens, Gary R.; Kristy, Rita M.

In: Investigative Radiology, Vol. 35, No. 7, 07.2000, p. 412-419.

Research output: Contribution to journalArticle

Grossman, RI, Rubin, DL, Hunter, G, Haughton, VM, Lee, D, Sze, G, Kühn, MJ, Maravilla, K, Raymond, TU, Heindel, W, Wippold, FJ, Leeds, N, Zelch, J, Jinkins, JR, Grodd, W, Truwit, C, Kanal, E, Provenzale, JM, Ramsey, R, Simon, J, Brunberg, JA, Stevens, GR & Kristy, RM 2000, 'Magnetic resonance imaging in patients with central nervous system pathology: A comparison of OptiMARK (Gd-DTPA-BMEA) and Magnevist (Gd-DTPA)', Investigative Radiology, vol. 35, no. 7, pp. 412-419. https://doi.org/10.1097/00004424-200007000-00003
Grossman, Robert I. ; Rubin, Daniel L. ; Hunter, George ; Haughton, Victor M. ; Lee, Donald ; Sze, Gordon ; Kühn, Matthew J. ; Maravilla, Kenneth ; Raymond, T. U. ; Heindel, Walter ; Wippold, Franz J. ; Leeds, Norman ; Zelch, James ; Jinkins, J. Randy ; Grodd, Wolfgang ; Truwit, Charles ; Kanal, Emanuel ; Provenzale, James M. ; Ramsey, Ruth ; Simon, Jack ; Brunberg, James A ; Stevens, Gary R. ; Kristy, Rita M. / Magnetic resonance imaging in patients with central nervous system pathology : A comparison of OptiMARK (Gd-DTPA-BMEA) and Magnevist (Gd-DTPA). In: Investigative Radiology. 2000 ; Vol. 35, No. 7. pp. 412-419.
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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.",
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T2 - A comparison of OptiMARK (Gd-DTPA-BMEA) and Magnevist (Gd-DTPA)

AU - Grossman, Robert I.

AU - Rubin, Daniel L.

AU - Hunter, George

AU - Haughton, Victor M.

AU - Lee, Donald

AU - Sze, Gordon

AU - Kühn, Matthew J.

AU - Maravilla, Kenneth

AU - Raymond, T. U.

AU - Heindel, Walter

AU - Wippold, Franz J.

AU - Leeds, Norman

AU - Zelch, James

AU - Jinkins, J. Randy

AU - Grodd, Wolfgang

AU - Truwit, Charles

AU - Kanal, Emanuel

AU - Provenzale, James M.

AU - Ramsey, Ruth

AU - Simon, Jack

AU - Brunberg, James A

AU - Stevens, Gary R.

AU - Kristy, Rita M.

PY - 2000/7

Y1 - 2000/7

N2 - 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.

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KW - Central nervous system pathology

KW - Contrast agents

KW - Gadolinium

KW - Lesions

KW - Magnetic resonance imaging

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