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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Magnetic Resonance Imaging (MRI)

Intervention / Treatment
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* Drug: Clariscan
* Other: Gadolinium-Based Contrast Agents


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clariscan 0.5 mmol/ml<br>Participants will receive Clariscan 0.5 mmol/ml injection as apart of clinical practice at the medical discretion of the prescribing physician. | Drug: Clariscan<br>* 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.<br>|
| All Gadolinium-Based Contrast Agents (GBCAs)<br>Participants will receive GBCA as part of clinical practice at the medical discretion of the prescribing physician. | Other: Gadolinium-Based Contrast Agents<br>* All GBCAs will be selected by the sites and recorded as by the brand names.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pattern of Use of GBCAs in Magnetic Resonance Imaging (MRI) Centres | 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. | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Visualization of the Contrast-Enhanced Magnetic Resonance (CE-MR) Image, Based on the Local Radiologist Assessment | Quality of image will be assessed by the local reporting radiologist on a 4-point Likert scale. For cardiovascular magnetic resonance angiography (MRA), qualitative assessment will be performed by blinded readers and assess image quality on a scale of 1 to 4 as 1=poor image quality and blurring of the arterial segment; 2=fair image quality, inadequate arterial enhancement for confident diagnosis; 3=good image quality and arterial enhancement, adequate for confident diagnosis; 4=excellent image quality and arterial enhancement, for highly confident diagnosis. For Magnetic resonance imaging (MRI), characterisation of the lesion (or most representative lesion, i.e., enhancing and/or largest if there will be >1 lesion present) will be assessed on a 4-point scale as 1= poor, inadequate; 2= fair, partial; 3= good, adequate; 4= excellent. | Post-image acquisition on Day 1 | 
| Change in Diagnostic Confidence (Evaluated by Local Radiologist) in Pre-Contrast and Post-Contrast CE-MR Examination Results | For each participant based on the most representative lesion. All available sequences (e.g., fluid attenuation inversion recovery [FLAIR], T2, and T1 with and without contrast administration) will be available for readers to review and evaluate. Before reviewing the CE-MR image, the radiologist will be asked to enter the confidence to make a diagnosis for the participant as a whole number between 0% to 100% based only on the non-enhanced image. The radiologist will then enter the diagnostic confidence as a whole number between 0% to 100% after the CE-MR scan results are read. This will be used to calculate the change in diagnostic confidence in this study by the local radiologist for all GBCAs including Clariscan. | Pre and post administration on Day 1 | 
| Customer Satisfaction Survey, Based on the Reports by the Local Nurse/Radiology Technician | Customer satisfaction survey was reported once per centre by MR nurse/technician from the investigator's staff - Quality of packaging including bottles, syringe, marking, pack size available. This will be recorded once for each GBCA used at the study centre as an overall impression and rated as: 1 = can be improved; 2 = good; 3 = excellent. | Upto end of recruitment (upto 90 days) | 
| Percentage of Participants With Treatment-Related Adverse Events (AEs) |  | Up to 3 months |