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Related Experiment Videos

[The endorem tolerance profile]

M Laniado1, A Chachuat

  • 1Abteilung für Radiologische Diagnostik, Eberhard-Karls-Universität, Tübingen.

Der Radiologe
|November 1, 1995
PubMed
Summary

ENDOREM, a superparamagnetic iron oxide contrast agent, is well-tolerated for liver and spleen MRI. Clinical trials show a low side effect rate, with lower back pain being the most common but rarely severe.

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Area of Science:

  • Radiology
  • Medical Imaging
  • Pharmacology

Background:

  • ENDOREM is a dextran-coated iron oxide superparamagnetic contrast agent.
  • It is designed for magnetic resonance imaging (MRI) of the liver and spleen.
  • Particle size ranges from 120-180 nm with an iron concentration of 0.2 mol/l.

Purpose of the Study:

  • To evaluate the safety and tolerability of ENDOREM.
  • To assess side effects and clinical relevance of observed changes.
  • To establish optimal dosing and infusion protocols for ENDOREM.

Main Methods:

  • Clinical trials conducted in Japan, USA, and Europe.
  • Patients received ENDOREM infused in 100 ml glucose 5% over approximately 30 min.
  • Doses varied: 10 micromol Fe/kg (Japan, USA) and 15 micromol Fe/kg (Europe).

Main Results:

  • Overall side effect rates ranged from 6.1% (Japan) to 10.3% (Europe).
  • Lower back pain was the most frequent side effect, but rarely required infusion cessation or medication.
  • Transient increases in serum iron and ferritin, with decreases in iron binding capacity, were observed. No clinically significant changes in vital signs were noted.

Conclusions:

  • ENDOREM is a well-tolerated contrast agent for liver and spleen MRI.
  • The recommended biphasic infusion protocol and dosage (15 micromol Fe/kg) ensure good tolerability.
  • Monitoring for transient changes in iron parameters is advisable.

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