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

GE Healthcare2,118 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

2,118

Conditions

Magnetic Resonance Imaging (MRI)

Interventions

ClariscanDRUG

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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)

Locations (2)

Radiology and Nuclear Medicine Ludwigshafen, Otto-Stabel Str. 2-4

Ludwigshafen, Germany

University of Oslo, Division of Radiology and Nuclear Medicine, P.O. Box 1072, Blindern

Oslo, Norway

Outcomes

Primary Outcomes

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

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

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

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)

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

Time frame: Up to 3 months