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 population

Eligibility criteria

Groups and cohorts

• 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.

  Drug: Clariscan

• All Gadolinium-Based Contrast Agents (GBCAs)

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

  Other: Gadolinium-Based Contrast Agents

Interventions

• DrugClariscan

  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.

• OtherGadolinium-Based Contrast Agents

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

Primary outcomes

1. 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.

   Time frame: Up to 3 months

Secondary outcomes

1. 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.

   Time frame: Post-image acquisition on Day 1

2. 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.

   Time frame: Pre and post administration on Day 1

3. 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.

   Time frame: Upto end of recruitment (upto 90 days)

4. Percentage of Participants With Treatment-Related Adverse Events (AEs)

   Time frame: Up to 3 months

Other outcomes

1. Quality of Visualization of the Contrast-Enhanced Magnetic Resonance (CE-MR) Image, Based on the Assessment by MR Experts

   The anonymised images will be blindly analysed by an expert MR radiologist panel to assess the quality of images. The first 50 images will be analysed in a 1:1 ratio for Clariscan and other GBCAs, i.e., the first consecutive 25 images for Clariscan and the first consecutive 25 images of the other GBCAs (excluding liver-specific GBCAs). This analysis will be performed at a later date and not part of the initial read out of the study.

   Time frame: Within 18 months from study start date

Individual participant data

Plan to share: No