Status:

COMPLETED

Post-marketing Safety Study in Participants of All Pathologies Who Receive Gadolinium-Based Contrast Agents (GBCAs) for Contrast-Enhanced Magnetic Resonance Imaging (MR) Examination

Lead Sponsor:

GE Healthcare

Conditions:

Magnetic Resonance Imaging (MRI)

Eligibility:

All Genders

Brief Summary

The purpose of this study is to prospectively collect data on the pattern of use for gadolinium-based contrast agents (GBCAs) in real-life setting with special reference to Clariscan after its commerc...

Eligibility Criteria

Inclusion

  • Participants may be included in the study if they meet all of the following criteria:
  • Participants of all ages and both male/females
  • Participants of all pathologies who require contrast-enhanced magnetic resonance (CE-MR) imaging as part of their diagnostic work up and the radiologist/physician has made the decision to use extracellular gadolinium-based contrast agents (GBCAs) as part of routine clinical practice
  • Participants Who Provide informed consent to participate in study

Exclusion

  • Use of liver-specific GBCAs (Primovist and MultiHance when used for liver excretion properties)

Key Trial Info

Start Date :

December 17 2018

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 11 2019

Estimated Enrollment :

2118 Patients enrolled

Trial Details

Trial ID

NCT03455283

Start Date

December 17 2018

End Date

November 11 2019

Last Update

December 4 2019

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Radiology and Nuclear Medicine Ludwigshafen, Otto-Stabel Str. 2-4

Ludwigshafen, Germany, 67059

2

University of Oslo, Division of Radiology and Nuclear Medicine, P.O. Box 1072, Blindern

Oslo, Norway, 0316