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

NCT03455283 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2118

Last updated 2019-12-04

No results posted yet for this study

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 commercial launch in Europe and in addition quality of images, diagnostic confidence and customer satisfaction will be assessed on a Likert scale by the local radiologist/technician and spontaneously reported immediate and delayed adverse events (AEs) to assess the effectiveness and safety profile of GBCAs in clinical practice respectively.

Conditions

  • Magnetic Resonance Imaging (MRI)

Interventions

DRUG

Clariscan

Clariscan 0.5 mmol/ml solution for injection will be administered as part of clinical practice according to the judgment of the site with regard to medical need.

OTHER

Gadolinium-Based Contrast Agents

All GBCAs will be selected by the sites and recorded as by the brand names.

Sponsors & Collaborators

  • GE Healthcare

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-17
Primary Completion
2019-11-11
Completion
2019-11-11

Countries

  • Germany
  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03455283 on ClinicalTrials.gov