A study of pattern of use for gadolinium-based contrast agents (GBCAs) in patients undergoing contrast-enhanced magnetic resonance (CE-MR) examination - a prospective, multicentre, observational study (GBCA Observational study)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (V08CA) Paramagnetic contrast media

  Paramagnetic contrast media

Population studied

• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  5400

Study design details

• Main study objective:
  To understand the pattern of use of GBCAs in magnetic resonance imaging (MRI) centres in Europe.
• Data analysis plan:
  The pattern of use for GBCAs for MR (MRA/MRI) examination will be summarised for all GBCAs pooled, for non-Clariscan GBCAs pooled, and for all individual GBCAs administered during the study, including Clariscan. The overall pattern of use will be assessed based on summary data from a number of different centre, investigator, and patient-level variables.A qualitative analysis of these variables will be performed describing the overall pattern of use, referral pattern, and challenges in a radiological practice. Additional details are available in the Clinical Trial Protocol.