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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- GE Healthcare
- Enrollment
- 2,118
- Locations
- 2
- Primary Endpoint
- Pattern of Use of GBCAs in Magnetic Resonance Imaging (MRI) Centres
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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.
Intervention: Clariscan (Drug)
All Gadolinium-Based Contrast Agents (GBCAs)
Participants will receive GBCA as part of clinical practice at the medical discretion of the prescribing physician.
Intervention: Gadolinium-Based Contrast Agents (Other)
Outcomes
Primary Outcomes
Pattern of Use of GBCAs in Magnetic Resonance Imaging (MRI) Centres
Time Frame: Up to 3 months
The Pattern of use will be assessed on summary data collected from: number of radiological procedures (including ultrasound, MR, computed tomography \[CT\] scan, fluoroscopy, X-ray, single-photon emission CT \[SPECT\], and positron emission tomography \[PET\] examinations), number of MR machines, number of enhanced and non-enhanced procedures, characteristics of the treated population (age, gender, BMI), dose indication, referring physician (seniority or specialty) performed by the study centre, investigator and patient-level variables. A qualitative analysis of these variables will be performed describing the overall pattern of use, referral pattern, and challenges in a radiological practice.
Secondary Outcomes
- Quality of Visualization of the Contrast-Enhanced Magnetic Resonance (CE-MR) Image, Based on the Local Radiologist Assessment(Post-image acquisition on Day 1)
- Change in Diagnostic Confidence (Evaluated by Local Radiologist) in Pre-Contrast and Post-Contrast CE-MR Examination Results(Pre and post administration on Day 1)
- Customer Satisfaction Survey, Based on the Reports by the Local Nurse/Radiology Technician(Upto end of recruitment (upto 90 days))
- Percentage of Participants With Treatment-Related Adverse Events (AEs)(Up to 3 months)