Clinical trial NCT03455283: Post-marketing Safety Study in Participants of All Pathologies Who Receive Gadolinium-Based Contrast Agents (GBCAs) for Contrast-Enhanced Magnetic Resonance Imaging (MR) Examination
Official title: A Study of Pattern of Use for Gadolinium-Based Contrast Agents (GBCAs) in Patients Undergoing Contrast-Enhanced Magnetic Resonance (CE-MR) Examination - A Prospective, Multicenter, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Magnetic Resonance Imaging (MRI)
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2018-03-06
Enrollment: 2118
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants routinely evaluated with CE-MR in one of 17 European radiology centres. Eligible centres will have Clariscan included on the formulary for Magnetic resonance (MR) examinations and have electronic record of cumulative data and are willing to report the cumulative data at the end of the recruitment period. Only one investigator per centre will be selected to perform the MR examination for that centre as part of the study.

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.


Eligibility 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)

Primary outcomes:
measure: Pattern of Use of GBCAs in Magnetic Resonance Imaging (MRI) Centres
timeFrame: Up to 3 months
Secondary outcomes:
measure: Quality of Visualization of the Contrast-Enhanced Magnetic Resonance (CE-MR) Image, Based on the Local Radiologist Assessment
timeFrame: Post-image acquisition on Day 1
measure: Change in Diagnostic Confidence (Evaluated by Local Radiologist) in Pre-Contrast and Post-Contrast CE-MR Examination Results
timeFrame: Pre and post administration on Day 1
measure: Customer Satisfaction Survey, Based on the Reports by the Local Nurse/Radiology Technician
timeFrame: Upto end of recruitment (upto 90 days)
measure: Percentage of Participants With Treatment-Related Adverse Events (AEs)
timeFrame: Up to 3 months
Other outcomes:
measure: Quality of Visualization of the Contrast-Enhanced Magnetic Resonance (CE-MR) Image, Based on the Assessment by MR Experts
timeFrame: Within 18 months from study start date
Locations:
city: Ludwigshafen
country: Germany
facility: Radiology and Nuclear Medicine Ludwigshafen, Otto-Stabel Str. 2-4
city: Oslo
country: Norway
facility: University of Oslo, Division of Radiology and Nuclear Medicine, P.O. Box 1072, Blindern
Study officials:
References: