Efficacy and safety of mangafodipir trisodium (MnDPDP) injection for hepatic MRI in adults: results of the U.S. Multicenter phase III clinical trials. Efficacy of early imaging

J Magn Reson Imaging. 2000 Nov;12(5):689-701. doi: 10.1002/1522-2586(200011)12:5<689::aid-jmri5>3.0.co;2-z.

Abstract

The efficacy of contrast-enhanced magnetic resonance imaging (MRI) for detecting and characterizing, or excluding, hepatic masses was assessed in 404 patients, following the intravenous administration of mangafodipir trisodium (MnDPDP) injection, a hepatic MRI contrast agent. An initial contrast-enhanced computed tomography (CT) examination was followed by unenhanced MRI, injection of MnDPDP (5 micromol/kg IV), and enhanced MRI at 15 minutes post injection. Agreement of the radiologic diagnoses with the patients' final diagnoses was higher for enhanced MRI and for the combined unenhanced and enhanced MRI evaluations than for unenhanced MRI alone or enhanced CT using the clinical diagnosis as the gold standard. Mangafodipir-enhanced MRI uniquely provided additional diagnostic information in 48% of the patients, and patient management was consequently altered in 6% of the patients. MnDPDP-enhanced MRI was comparable or superior to unenhanced MRI and enhanced CT for the detection, classification, and diagnosis of focal liver lesions in patients with known or suspected focal liver disease.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Contrast Media*
  • Diagnosis, Differential
  • Edetic Acid / adverse effects
  • Edetic Acid / analogs & derivatives*
  • Female
  • Humans
  • Image Enhancement*
  • Injections, Intravenous
  • Liver Cirrhosis / diagnosis*
  • Liver Neoplasms / diagnosis*
  • Magnetic Resonance Imaging / methods*
  • Male
  • Middle Aged
  • Pyridoxal Phosphate / adverse effects
  • Pyridoxal Phosphate / analogs & derivatives*
  • Sensitivity and Specificity

Substances

  • Contrast Media
  • Pyridoxal Phosphate
  • Edetic Acid
  • N,N'-bis(pyridoxal-5-phosphate)ethylenediamine-N,N'-diacetic acid