Phase II clinical evaluation of Gd-EOB-DTPA: dose, safety aspects, and pulse sequence

Radiology. 1996 Apr;199(1):177-83. doi: 10.1148/radiology.199.1.8633143.

Abstract

Purpose: To investigate the efficacy of gadolinium ethoxybenzyl diethylenetriaminepentaacetic acid (Gd-EOB-DTPA) in the detection of focal liver lesions with respect to dose, side effects, and pulse sequence.

Materials and methods: A randomized double-blinded trial was performed in 33 patients with focal solid liver lesions. A bolus of Gd-EOB-DTPA, a liver-specific contrast agent, was intravenously administered at three different doses (12.5, 25, and 50 mumol per kilogram of body weight). Magnetic resonance imaging with different T1-weighted techniques was performed 20 and 45 minutes after administration of Gd-EOB-DTPA. Changes in liver signal intensity, lesion-liver contrast-to-noise ration (C/N), detectable liver lesions, side effects, and adverse events were evaluated.

Results: Gd-EOB-DTPA significantly (P < .05) increased liver signal intensity and lesion-liver C/N within the dose range tested. Lesion detection was improved 20 and 45 minutes after administration of Gd-EOB-DTPA. A dose of 12.5 mumol was sufficient for the detection of focal liver lesions, and the breath-hold, T1-weighted, fast low-angle shot pulse sequence was the most useful. No significant changes in vital signs, clinical laboratory test results, and urinalysis were observed.

Conclusion: Gd-EOB-DTPA is an efficient, diagnostically useful, and safe contrast agent.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Contrast Media* / administration & dosage
  • Contrast Media* / adverse effects
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Gadolinium DTPA*
  • Gadolinium* / administration & dosage
  • Gadolinium* / adverse effects
  • Humans
  • Liver / pathology
  • Liver Diseases / diagnosis*
  • Liver Neoplasms / diagnosis*
  • Liver Neoplasms / secondary
  • Magnetic Resonance Imaging / methods*
  • Male
  • Middle Aged
  • Organometallic Compounds* / administration & dosage
  • Organometallic Compounds* / adverse effects
  • Pentetic Acid / administration & dosage
  • Pentetic Acid / adverse effects
  • Pentetic Acid / analogs & derivatives*
  • Time Factors

Substances

  • Contrast Media
  • Organometallic Compounds
  • gadolinium ethoxybenzyl DTPA
  • Pentetic Acid
  • Gadolinium
  • Gadolinium DTPA