The study demonstrated a significant increase in diagnostic confidence after GBCA use and confirmed the good safety profile of GBCAs, with comparable results for all agents used.Ĭontrast-enhanced magnetic resonance (CE-MR) is a widely used imaging technique crucial for several indications and diagnoses. This European study confirmed that GBCAs are used appropriately in Europe for a wide range of indications. Four patients reported AEs (0.19%), with only 1 (0.05%) considered serious. ![]() Image quality was considered excellent or good in 96.1% of patients and across all GBCA. GBCA use increased confidence in diagnosis in 96.2% of examinations and resulted in a change in radiological diagnosis in 73.9% of patients. Mean GBCA doses were 0.10 mmol/kg body weight, except for Gadovist (mean 0.12 mmol/kg). Most were performed in CNS-related indications (46.2%). Clariscan, Dotarem (gadoteric acid), Gadovist (gadobutrol) and ProHance (gadoteridol) were utilised in 1513 (71.4%), 356 (16.8%), 237 (11.2%) and 12 (0.6%) patients, respectively. ResultsĢ118 patients were included from 8 centres across 5 European countries between December 2018 and November 2019. Safety data were collected by spontaneous patient adverse event (AE) reporting. Assessment of effectiveness included changes in radiological diagnosis, diagnostic confidence and image quality. Reported usage patterns included indication, referral and examination details. Prospective, cross-sectional, multicentre, observational study in patients undergoing contrast-enhanced magnetic resonance. The study aims to understand the patterns of (GBCA) use, and to study the effectiveness and safety of GBCA in routine practice across Europe. To report any unexpected adverse or serious events associated with the use of this drug, please contact the FDA MedWatch program listed below.The EU gadolinium-based contrast agents (GBCA) market has changed in recent years due to the European Medicines Agency decision to suspend the marketing authorisation of linear GBCA and the marketing authorisation of new generic macrocyclic GBCA. Gadolinium-based contrast agents are rare earth metals that are usually given through an IV in the arm.įor more information about MRI and their safety and risks, please see the Center for Radiological Health’s consumer information page. ![]() A typical MRI scan last from 20 - 90 minutes, depending on the part of the body being imaged.įor some MRI exams, intravenous (IV) drugs, such as gadolinium-based contrast agents (GBCAs) are used to change the contrast of the MR image. Radio waves are sent from and received by a transmitter/receiver in the machine, and these signals are used to make digital images of the scanned area of the body. The signal in an MR image comes mainly from the protons in fat and water molecules in the body.ĭuring an MRI exam, an electric current is passed through coiled wires to create a temporary magnetic field in a patient’s body. MRI scanners use strong magnetic fields and radio waves (radiofrequency energy) to make images. Magnetic Resonance Imaging (MRI) is a medical imaging procedure for making images of the internal structures of the body. Gadolinium-Based Contrast Agents (GBCA) are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA).
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