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Objectives: To evaluate compliance with the available recommendations, we assessed the current clinical practice of imaging in the evaluation of multiple sclerosis (MS). Methods: An online questionnaire was emailed to all members and affiliates. Information was gathered on applied MR imaging protocols, gadolinium-based contrast agents (GBCA) use and image analysis. We compared the survey results with the Magnetic Resonance Imaging in MS (MAGNIMS) recommendations considered as the reference standard. Results: A total of 428 entries were received from 44 countries. Of these, 82% of responders were neuroradiologists. 55% performed more than ten scans per week for MS imaging. The systematic use of 3 T is rare (18%). Over 90% follow specific protocol recommendations with 3D FLAIR, T2-weighted and DWI being the most frequently used sequences. Over 50% use SWI at initial diagnosis and 3D gradient-echo T1-weighted imaging is the most used MRI sequence for pre- and post-contrast imaging. Mismatches with recommendations were identified including the use of only one sagittal T2-weighted sequence for spinal cord imaging, the systematic use of GBCA at follow-up (over 30% of institutions), a delay time shorter than 5 min after GBCA administration (25%) and an inadequate follow-up duration in pediatric acute disseminated encephalomyelitis (80%). There is scarce use of automated software to compare images or to assess atrophy (13% and 7%). The proportions do not differ significantly between academic and non-academic institutions. Conclusions: While current practice in MS imaging is rather homogeneous across Europe, our survey suggests that recommendations are only partially followed. Clinical relevance statement: Hurdles were identified, mainly in the areas of GBCA use, spinal cord imaging, underuse of specific MRI sequences and monitoring strategies. This work will help radiologists to identify the mismatches between their own practices and the recommendations and act upon them. Key Points: • While current practice in MS imaging is rather homogeneous across Europe, our survey suggests that available recommendations are only partially followed. • Several hurdles have been identified through the survey that mainly lies in the areas of GBCA use, spinal cord imaging, underuse of specific MRI sequences and monitoring strategies. [ABSTRACT FROM AUTHOR]

Rare Earth Element and Yttrium (REY) have become emerging contaminants in the hydrosphere. REY contamination has been recorded worldwide and raises concerns about the REY's (eco)toxicity. Nevertheless, their environmental fate and the mechanisms of bioaccumulation remain unclear. We investigated the shells of three invasive mussel species from four temperate rivers (Rhine, Danube, Elbe and Weser) and three tributaries (Havel, Regen and Isar) in Central Europe. REY concentrations in shells are in the μg/kg range and up to five orders of magnitude higher than those in ambient water. Interspecies comparison showed that Dreissena shells show systematically higher REY concentrations than Corbicula shells. Due to more stable complexation of heavy than light REY in river water or in the extrapallial fluid, light REY are preferentially incorporated into the shells. Anthropogenic La from fluid catalytic cracking catalysts is bioaccumulated in mussel shells from the lower reaches of the Rhine River. However, the anthropogenic Gd from MRI contrast agents released from wastewater treatment plants, that is observed in rivers worldwide, is not incorporated into mussel shells, revealing its conservative biogeochemical behavior. [Display omitted] • All invasive freshwater mussel studied bioaccumulate rare earths and yttrium. • Stronger bioaccumulation by Dreissena than by Corbicula shells. • Preferential bioaccumulation of light over heavy rare earth elements. • All species incorporate anthropogenic lanthanum into their shells. • All species discriminate against anthropogenic gadolinium in their shells. [ABSTRACT FROM AUTHOR]

Background: 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. The study aims to understand the patterns of (GBCA) use, and to study the effectiveness and safety of GBCA in routine practice across Europe. Methods: Prospective, cross-sectional, multicentre, observational study in patients undergoing contrast-enhanced magnetic resonance. Reported usage patterns included indication, referral and examination details. Assessment of effectiveness included changes in radiological diagnosis, diagnostic confidence and image quality. Safety data were collected by spontaneous patient adverse event (AE) reporting. Results: 2118 patients were included from 8 centres across 5 European countries between December 2018 and November 2019. 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. Most were performed in CNS-related indications (46.2%). Mean GBCA doses were 0.10 mmol/kg body weight, except for Gadovist (mean 0.12 mmol/kg). GBCA use increased confidence in diagnosis in 96.2% of examinations and resulted in a change in radiological diagnosis in 73.9% of patients. Image quality was considered excellent or good in 96.1% of patients and across all GBCA. Four patients reported AEs (0.19%), with only 1 (0.05%) considered serious. Conclusions: This European study confirmed that GBCAs are used appropriately in Europe for a wide range of indications. 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. [ABSTRACT FROM AUTHOR]

Objectives: To perform an online survey about the use of magnetic resonance arthrography (MRA) in clinical practice.Methods: We administered an online survey to all 1,550 members of the European Society of Musculoskeletal Radiology (ESSR) about MRA asking ten different questions. Subgroup analysis was performed between general and orthopaedic hospitals using χ2 and Mann-Whitney U statistics.Results: One-hundred forty-eight answers were included (148/1,550, 9.5% of ESSR members). A median of 3,000 (interquartile range: 1,567.5-5,324.5) musculoskeletal MR examinations and a median of 125.5 MRAs (50.75-249) per institution were performed in 2016. Ratio between MRA and musculoskeletal MR was 4.7% (1.6%-9.0%). Using MRA, the most investigated joint was the shoulder followed by the hip (96.6%). The most common indications were the evaluation of instability, labrum, and rotator cuff (85.1%). Fluoroscopy represented the preferred injection guidance. A self-prepared mixture of Gadolinium/saline is preferred in general hospitals, while pre-diluted Gadolinium-based syringes are mainly used in orthopaedic hospitals (P=.010). The number of MRA performed at orthopaedic hospitals (284;83.75-449.50) was higher (P=.006) than that performed at general hospitals (115.50;44.75-234.25).Conclusions: One out of twenty MR examinations is a MRA, with higher prevalence in orthopaedic hospitals. The shoulder and the hip are the most investigated joints. Instability, labrum, and cuff are the most common indications.Key Points: • The most common MRAs are shoulder and hip (96.6% of answers). • Most common clinical indications for MRA are instability, labrum, and rotator cuff (85.1% of answers). • Fluoroscopy represents the preferred guidance to inject joints (61.0% of answers). • The median number of MRA performed at orthopaedic hospitals (n=284) was significantly higher (P=.006) than that performed at general hospitals (n=115.50). • A self-prepared mixture of Gadolinium/saline solution is preferred in general hospitals (64.8%) compared to orthopaedic hospitals (36.0%; P=0.010). [ABSTRACT FROM AUTHOR]

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) earlier this year recommended to suspend some marketing authorisations for Gadolinium Containing Contrast Agents (GCCAs) based on linear chelators due to the potential risk of gadolinium retention in the human body. These recommendations have recently been re-evaluated by EMA's Committee for Medicinal Products for Human Use (CHMP), and confirmed the final opinion of the European Medicines Agency. This editorial provides an overview of the available GCCAs and summarises the recent evidence of gadolinium retention. Moreover, a critical appraisal of the strengths and limitations of the scientific evidence currently available on gadolinium retention is given.Key Points: • EMA recommended suspension of some EU marketing authorisations of four linear GCCAs. • Brain MRI findings indicating gadolinium retention have been confirmed by mass spectrometry. • Current scientific evidence for gadolinium retention has several methodological limitations. • No clear clinical evidence exists indicating that gadolinium retention causes neurotoxicity. • Long-term safety of GCCAs, however, remains unclear. [ABSTRACT FROM AUTHOR]

Objectives: Specifically we aim to demonstrate that the results of our earlier safety data hold true in this much larger multi-national and multi-ethnical population. Background: We sought to re-evaluate the frequency, manifestations, and severity of acute adverse reactions associated with administration of several gadolinium-based contrast agents during routine CMR on a European level. Methods: Multi-centre, multi-national, and multi-ethnical registry with consecutive enrolment of patients in 57 European centres. Results: During the current observation 37788 doses of Gadolinium based contrast agent were administered to 37788 patients. The mean dose was 24.7 ml (range 5-80 ml), which is equivalent to 0.123 mmol/kg (range 0.01 - 0.3 mmol/kg). Forty-five acute adverse reactions due to contrast administration occurred (0.12 %). Most reactions were classified as mild (43 of 45) according to the American College of Radiology definition. The most frequent complaints following contrast administration were rashes and hives (15 of 45), followed by nausea (10 of 45) and flushes (10 of 45). The event rate ranged from 0.05 % (linear non-ionic agent gadodiamide) to 0.42 % (linear ionic agent gadobenate dimeglumine). Interestingly, we also found different event rates between the three main indications for CMR ranging from 0.05 % (risk stratification in suspected CAD) to 0.22 % (viability in known CAD). Conclusions: The current data indicate that the results of the earlier safety data hold true in this much larger multi-national and multi-ethnical population. Thus, the "off-label" use of Gadolinium based contrast in cardiovascular MR should be regarded as safe concerning the frequency, manifestation and severity of acute events. [ABSTRACT FROM AUTHOR]

The article discusses the clinical features of nephrogenic systemic fibrosis (NFR), as well as the use of Gadolinium based contrast agents (GBCA) in patients at risk of NSF. It says that GBCA makes NSF a possible side-effect of contrast enhanced magnetic resonance imaging and offers a preventive opportunity by limiting the use of GBCA in renal failure patients. It states that medical societies in Europe and North America have created guidelines for the utilization of GBCA.

After the initial report in 2014 on T1-weighted (T1w) hyperintensity of deep brain nuclei following serial injections of linear gadolinium-based contrast agents (GBCAs), a multitude of studies on the potential of the marketed GBCAs to cause T1w hyperintensity in the brain have been published. The vast majority of these studies found a signal intensity (SI) increase for linear GBCAs in the brain-first and foremost in the dentate nucleus-while no SI increase was found for macrocyclic GBCAs. However, the scientific debate about this finding is kept alive by the fact that SI differences do not unequivocally represent the amount of gadolinium retained. Since the study design of the SI measurement in various brain structures is relatively simple, MRI studies investigating gadolinium-dependent T1w hyperintensity are currently conducted at multiple institutions worldwide. However, methodological mistakes may result in flawed conclusions. In this position statement, we assess the methodological basis of the published retrospective studies and define quality standards for future studies to give guidance to the scientific community and to help identify studies with potentially flawed methodology and misleading results. KEY POINTS: • A multitude of studies has been published on the potential of the marketed GBCAs to cause T1w hyperintensity in the brain. • The gadolinium-dependent T1w hyperintensity in the brain depends on patient's history, types of GBCAs used (i.e., linear vs. macrocyclic GBCAs) and MR imaging setup and protocols. • Quality standards for the design of future studies are needed to standardize methodology and avoid potentially misleading results from retrospective studies.

Objectives: To assess the incidence of acute adverse events (AAEs) in gadolinium-enhanced cardiac magnetic resonance (CMR) imaging., Methods: Gadolinium-based contrast agent (GBCA)-enhanced CMR data from the multinational, multicenter European Society of Cardiovascular Radiology MRCT Registry was included. AAE severity was classified according to the American College of Radiology Manual on Contrast Media (mild, moderate, severe). Multivariable generalized linear mixed effect models were used to assess the likelihood of AAEs in various GBCA, adjusting for pharmacological stressor, main indications (i.e., suspected or known coronary artery disease or myocarditis), age, sex, and submitting center as a random effect., Results: In the study population of 72,839 GBCA-enhanced CMRs, a total of 260 AAEs were reported (0.36%), with a minority of severe AAEs (n = 24, 0.033%). Allergic-like AAEs were less likely than physiologic AAEs (29% versus 71%). Patients without pharmacological stress imaging had a lower AAE rate (0.22%) compared to stress imaging (0.75%), with the highest AAE rates for regadenoson (2.95%). AAE rates also varied by GBCA subtype (overall p < 0.001). There was significant interaction between GBCA and pharmacological stressor (interaction p = 0.025), with AAE rates ranging between 0 and 10% for certain GBCA/stressor combinations. There was further marginal evidence that higher GBCA volume was associated with higher AAE incidence (OR = 1.02, p = 0.05)., Conclusion: GBCA-enhanced CMR imaging demonstrates low AAE rates comparable to those of other body regions. AAE likelihood correlates with GBCA subtype, pharmacological stressor, and imaging indication. Intravenous fluid administration in patients with cardiac impairment might contribute to these findings., Key Points: • Acute adverse event rates in cardiac magnetic resonance (CMR) imaging with gadolinium-based contrast agents (GBCAs) are low (0.36%), especially for severe adverse events (0.033%). • Mild and moderate adverse events are more frequent during stress CMR imaging. • Physiologic AAEs are more common than allergic AAEs in CMR imaging.

Gadolinium (Gd)-based contrast agents have been routinely used worldwide in diagnostic MRI since 1988. All routinely applied contrast agents for clinical use were considered extremely safe with regard to tolerance, adverse effects and diagnostic efficacy and when used at Food and Drug Administration-approved doses. With the identification of Gd-associated disorders, namely nephrogenic systemic fibrosis and adverse reactions, and in the longer term Gd-retention in the brain, this view changed and led to the withdrawal or restriction of approval of linear Gd chelates in Europe. Even though Gd deposition in different human body areas was described very early, recently published literature of intracerebral accumulation of contrast agents as well as deposition in bone have created surprising attention. Not only was the fact of Gd deposition in the body well known for many years, but there is currently no clinical evidence of patient symptoms and no resulting health issues of patients have been observed yet. The expression "gadolinium deposition disease" has been termed by active patient advocacy groups with an online presence with reports of individual members stating a broad spectrum of disorders yielding a large symptom complex after administration of Gd-based contrast agents without evidence of any pre-existing or otherwise underlying disease process which could explain the mentioned disorder.

Abstract: Objective: To determine the safety and tolerability of gadobutrol in a large number of non-selected patients from routine clinical radiology practices. Materials and methods: Six prospectively planned, observational surveillance studies were conducted at more than 300 institutions in Europe and Canada from 2000 to 2007. Demographic and medical status data, details of the diagnostic procedure, contrast agent administration and adverse drug reaction (ADR) data were collected using a standardized questionnaire. Results: A total of 14,299 patients were enrolled. The mean age of the patients was 53.7 years; 1.3% of the patients were <18 years old and 40.8% were 60 years or older. The body regions most frequently examined were head/neck/brain (54.3%), followed by spine (7.2%), pelvis/joints/limbs (6.7%) and multiple body regions (6.4%). Gadobutrol-enhanced magnetic resonance angiography (MRA) was performed in 14.7% of patients. Overall, the mean volume of gadobutrol administered for contrast-enhanced magnetic resonance imaging was 12mL (0.16mmol gadolinium [Gd]/kg body weight [BW]; mean BW: 75.5kg), whereas for contrast-enhanced MRA the mean volume was 15.7mL (0.21mmol Gd/kg BW). Seventy-eight of the 14,299 patients (0.55%) reported at least one ADR. Two (0.01%) serious ADRs were reported. The most frequently reported ADR was nausea, which occurred in 36 patients (0.25%). Conclusion: Gadobutrol 1.0M is very well tolerated and has a good safety profile. The occurrence of ADRs observed following the intravenous injection of gadobutrol is comparable with the published data of other Gd-based contrast agents. [Copyright &y& Elsevier]

Objective: This prospective multicenter intraindividual crossover study was designed to compare gadobenate dimeglumine and gadofosveset trisodium at approved doses with respect to the image quality and diagnostic performance of contrast-enhanced MR angiography (CE-MRA) in the detection of clinically relevant renal artery stenosis., Subjects and Methods: Thirty-nine subjects (17 men, 22 women; age range, 30-86 years; mean 62 +/- 13.3 [SD] years) with known or suspected renovascular disease underwent a first CE-MRA examination with 0.1 mmol/kg gadobenate dimeglumine and a second examination 3-12 days later with 0.03 mmol/kg gadofosveset. Identical T1-weighted spoiled gradient-refocused echo coronal first-pass images were acquired for 38 of the 39 patients. For 15 of the 38 patients, additional sagittal or axial images or both were acquired with gadofosveset during the steady-state phase. Thirty-four patients underwent digital subtraction angiography, which was the reference standard. Three independent blinded readers assessed source images and maximum-intensity-projection reconstructions to detect clinically relevant (> 50%) renal artery stenosis. Diagnostic performance (sensitivity, specificity, accuracy, positive and negative predictive values) was evaluated with the McNemar and Wald tests. Matched-pair determinations of diagnostic preference were evaluated with Wilcoxon's signed rank test. Reader agreement was determined with kappa analysis, and safety was assessed., Results: Comparison of first-pass images revealed superior sensitivity (75.7-86.5% vs 68.4-76.3%), specificity (92.1-98.6% vs 90.5-93.9%), accuracy (88.9-96.2% vs 85.9-90.3%), positive predictive value (70.0-94.1% vs 65.0-76.3%), and negative predictive value (94.0-96.6% vs 91.7-93.9%) with gadobenate dimeglumine. Significant superiority was noted for specificity (p < or = 0.02), accuracy (p < or = 0.005), and positive predictive value (p < or = 0.018). Steady-state images showed no benefit of gadofosveset. Reader agreement was good to excellent (gadobenate dimeglumine, kappa = 0.855; gadofosveset, kappa = 0.776). Reader preference was for gadobenate dimeglumine in 11, 17, and 13 patients and for gadofosveset in five, four, and five patients. No safety concerns were noted., Conclusion: Better diagnostic performance and reader preference were found for gadobenate dimeglumine than gadofosveset in first-pass renal CE-MRA.

Recently, the clinical efficacy of interferon beta-1b (IFNbeta-1b) was demonstrated for secondary progressive (SP) multiple sclerosis in a European multicentre study. We evaluated the effect of IFNbeta-1b treatment on the rate of development of hypointense T(1) MRI lesions, a putative marker of axonal damage. Unenhanced T(1)-weighted images were obtained in a subgroup of 95 multiple sclerosis patients from five centres at 6-month intervals; this subgroup was similar to the total study population for all demographic, clinical and MRI parameters. An experienced observer blinded to the clinical data and treatment allocation measured volumes. The median baseline lesion load for hypointense T(1) lesions was 5.1 cm(3) for placebo-treated and 4.9 cm(3) for IFNbeta-1b-treated patients (P = 0.56). Placebo-treated patients showed an increase in T(1) lesion load by a median of 14% per year (P = 0.0002 compared with baseline); this was reduced to 7.7% per year in the IFNbeta-1b-treated patients (P = 0.003 versus placebo). In the IFNbeta-1b arm there was a statistically significant correlation between absolute change in Expanded Disability Status Scale scores and T(1) lesion load by month 36 (r = 0.38, P = 0.0015). In patients with SP multiple sclerosis, IFNbeta-1b treatment reduces the development of hypointense T(1) lesions, suggesting that reduced axonal damage in lesions may play a part in the beneficial effect that is observed clinically.