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 identification

• EU PAS number:
  EUPAS21473
• Study ID:
  29886
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Norway

  Poland

  Portugal

  Spain
• Study description:
  A prospective, multicentre, observational study in patients undergoing CE-MR examination as part of routine clinical practice. Patients will be invited to participate in the study only after the decision has been made by the physician to use contrast agents and Clariscan is already included in the formulary of the hospital/institution as an independent decision prior to investigator taking part in this study. Patients enrolledin the study will not be actively followed up to collect adverse events (AEs) or outcomes. Any spontaneously reported AEs/information will be recorded/reported by the investigators up to 7 days after the magnetic resonance (MR) procedure.
• Study status:
  Ongoing

Research institutions and networks

Institutions

GE Healthcare

Study timelines

Date when funding contract was signed

Planned:09/10/2017

Study start date

Planned:01/02/2018

Actual:17/12/2018

Data analysis start date

Planned:01/08/2019

Date of final study report

Planned:30/09/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GE Healthcare

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

CLA-17-01