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

General Electric (GE)

Status: Completed

Conditions: Magnetic Resonance Imaging (MRI)

Treatments: Drug: Clariscan; Other: Gadolinium-Based Contrast Agents

Study type: Observational

Funder types: Industry

Identifiers

NCT03455283

EUPAS21473 (Registry Identifier)

CLA-17-01

Details and patient eligibility

About

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.

Enrollment: 2,118 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: 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 Criteria:

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

Trial design

2,118 participants in 2 patient groups

Clariscan 0.5 mmol/ml

Description:

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

Treatment:

Drug: Clariscan

All Gadolinium-Based Contrast Agents (GBCAs)

Description:

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

Treatment:

Other: Gadolinium-Based Contrast Agents