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

NCT ID: NCT03455283

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2118 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-17
• Study Completion Date: 2019-11-11

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 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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Clariscan 0.5 mmol/ml

Participants will receive Clariscan 0.5 mmol/ml injection as apart of clinical practice at the medical discretion of the prescribing physician.

Clariscan

Intervention Type: DRUG

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.

All Gadolinium-Based Contrast Agents (GBCAs)

Participants will receive GBCA as part of clinical practice at the medical discretion of the prescribing physician.

Gadolinium-Based Contrast Agents

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DRUG

Gadolinium-Based Contrast Agents

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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 Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Ludwigshafen, , Germany

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

Oslo, , Norway

Countries

Germany; Norway

Other Identifiers

EUPAS21473

Identifier Type: REGISTRY

Identifier Source: secondary_id

CLA-17-01

Identifier Type: -

Identifier Source: org_study_id