Purpose of review:Use of gadolinium-based contrast agents (GBCA) in renal impairment is controversial, with physician and patient apprehension in acute kidney injury (AKI), chronic kidney disease (CKD), and dialysis because of concerns regarding nephrogenic systemic fibrosis (NSF). The position that GBCA are absolutely contraindicated in AKI, category G4 and G5 CKD (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2), and dialysis-dependent patients is outdated and may limit access to clinically necessary contrast-enhanced magnetic resonance imaging (MRI) examinations. This review and clinical practice guideline addresses the discrepancy between existing Canadian guidelines regarding use of GBCA in renal impairment and NSF.Sources of information:Published literature (including clinical trials, retrospective cohort series, review articles, and case reports), online registries, and direct manufacturer databases were searched for reported cases of NSF by class and specific GBCA and exposed patient population.Methods:A comprehensive review was conducted identifying cases of NSF and their association to class of GBCA, specific GBCA used, patient, and dose (when this information was available). Based on the available literature, consensus guidelines were developed by an expert panel of radiologists and nephrologists.Key findings:In patients with category G2 or G3 CKD (eGFR ≥ 30 and < 60 mL/min/1.73 m2), administration of standard doses of GBCA is safe and no additional precautions are necessary. In patients with AKI, with category G4 or G5 CKD (eGFR < 30 mL/min/1.73 m2) or on dialysis, administration of GBCA should be considered individually and alternative imaging modalities utilized whenever possible. If GBCA are necessary, newer GBCA may be administered with patient consent obtained by a physician (or their delegate) citing an exceedingly low risk (much less than 1%) of developing NSF. Standard GBCA dosing should be used; half or quarter dosing is not recommended and repeat injections should be avoided. Dialysis-dependent patients should receive dialysis; however, initiating dialysis or switching from peritoneal to hemodialysis to reduce the risk of NSF is unproven. Use of a macrocyclic ionic instead of macrocyclic nonionic GBCA or macrocyclic instead of newer linear GBCA to further prevent NSF is unproven. Gadopentetate dimeglumine, gadodiamide, and gadoversetamide remain absolutely contraindicated in patients with AKI, those with category G4 or G5 CKD, or those on dialysis. The panel agreed that screening for renal disease is important but less critical when using macrocyclic and newer linear GBCA. Monitoring for and reporting of potential cases of NSF in patients with AKI or CKD who have received GBCA is recommended.Limitations:Limited available literature (number of injections and use in renal impairment) regarding the use of gadoxetate disodium. Limited, but growing and generally high-quality, number of clinical trials evaluating GBCA administration in renal impairment. Limited data regarding the t...
Artificial intelligence (AI) software that analyzes medical images is becoming increasingly prevalent. Unlike earlier generations of AI software, which relied on expert knowledge to identify imaging features, machine learning approaches automatically learn to recognize these features. However, the promise of accurate personalized medicine can only be fulfilled with access to large quantities of medical data from patients. This data could be used for purposes such as predicting disease, diagnosis, treatment optimization, and prognostication. Radiology is positioned to lead development and implementation of AI algorithms and to manage the associated ethical and legal challenges. This white paper from the Canadian Association of Radiologists provides a framework for study of the legal and ethical issues related to AI in medical imaging, related to patient data (privacy, confidentiality, ownership, and sharing); algorithms (levels of autonomy, liability, and jurisprudence); practice (best practices and current legal framework); and finally, opportunities in AI from the perspective of a universal health care system.
Use of gadolinium-based contrast agents (GBCAs) in renal impairment is controversial, with physician and patient apprehension in acute kidney injury (AKI), chronic kidney disease (CKD), and dialysis because of concerns regarding nephrogenic systemic fibrosis (NSF). The position that GBCAs are absolutely contraindicated in AKI, CKD stage 4 or 5 (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m) and dialysis-dependent patients is outdated, and may limit access to clinically necessary contrast-enhanced MRI examinations. Following a comprehensive review of the literature and reported NSF cases to date, a committee of radiologists and nephrologists developed clinical practice guidelines to assist physicians in making decisions regarding GBCA administrations. In patients with mild-to-moderate CKD (eGFR ≥30 and <60 mL/min/1.73 m), administration of standard doses of GBCA is safe and no additional precautions are necessary. In patients with AKI, with severe CKD (eGFR <30 mL/min/1.73 m), or on dialysis, administration of GBCAs should be considered individually and alternative imaging modalities utilized whenever possible. If GBCAs are necessary, newer GBCAs may be administered with patient consent obtained by a physician (or their delegate), citing an exceedingly low risk (much less than 1%) of developing NSF. Standard GBCA dosing should be used; half or quarter dosing is not recommended and repeat injections should be avoided. Dialysis-dependent patients should receive dialysis; however, initiating dialysis or switching from peritoneal to hemodialysis to reduce the risk of NSF is unproven. Use of a macrocyclic ionic instead of macrocyclic nonionic GBCA or macrocyclic instead of newer linear GBCA to further prevent NSF is unproven. Gadopentetate dimeglumine, gadodiamide, and gadoversetamide remain absolutely contraindicated in patients with AKI, with stage 4 or 5 CKD, or on dialysis. The panel agreed that screening for renal disease is important but less critical when using macrocyclic and newer linear GBCAs. Monitoring for and reporting of potential cases of NSF in patients with AKI or CKD who have received GBCAs is recommended.
In 2017, the Canadian Association of Radiologists issued a clinical practice guideline (CPG) regarding the use of gadolinium-based contrast agents (GBCAs) in patients with acute kidney injury (AKI), chronic kidney disease (CKD), or on dialysis due to mounting evidence indicating that nephrogenic systemic fibrosis (NSF) occurs with extreme rarity or not at all when using Group II GBCAs or the Group III GBCA gadoxetic acid (compared to first generation Group I linear GBCAs). One of the goals of the work group was to re-evaluate the CPG after 24 months to determine the effect of more liberal use of GBCA on reported cases of NSF in patients with AKI, CKD Stage 4 or 5 (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m 2 ), or those that are dialysis-dependent. A comprehensive review of the literature was conducted by a subcommittee of the initial CPG panel between the dates of January 1, 2017-December 31, 2018 to identify new unconfounded cases of NSF linked to Group II or Group III GBCAs and an updated CPG developed. To our knowledge, when using a Group II or Group III GBCA between 2017-2018, only a single unconfounded case report of a fibrosing dermopathy has been reported in a patient who received gadobenate dimeglumine with Stage 2 CKD. No other unconfounded cases of NSF have been reported with Group II or III agents in during this timeframe. The subcommittee concluded that the main recommendations from the 2017 CPG should remain unaltered, but agreed that screening for renal disease in the outpatient setting is no longer justifiable, cost-effective or recommended. Patients on hemodialysis (HD) should, however, be identified prior to GBCA administration to arrange timely HD to optimize gadolinium clearance, although there remains no evidence that HD reduces the risk of NSF. When administering Group II or III GBCAs to patients with AKI, on dialysis or with severe CKD, informed consent relating to NSF is also no longer explicitly recommended. R esum eEn 2017, l'Association canadienne des radiologistes a publi e des lignes directrices de pratique clinique (LDPC) sur l'utilisation de produits de contraste a base de gadolinium (PCBG) chez des patients atteints d'insuffisance r enale aigu€ e (IRA), de n ephropathie chronique ou sous dialyse, en raison de l'accumulation de donn ees d emontrant que la fibrose syst emique n ephrog enique (FSN) se manifeste avec une raret e extrême, voire pas du tout, lors de l'emploi de PCBG du groupe II ou d'acide gadox etique-PCBG du groupe III (par rapport aux PCBG lin eaires du groupe I de premi ere g en eration). L'un des objectifs du groupe de travail etait de r e evaluer les LDPC apr es 24 mois pour d eterminer l'effet d'une utilisation plus g en erale de PCBG sur des cas signal es de FSN chez des patients atteints d'IRA ou de n ephropathie chronique de stade 4 ou 5 (d ebit de filtration glom erulaire estim e [DFGe] < 30 mL/min/1,73 m 2 ), ou dialys es. Une revue approfondie des publications a et e conduite par un sous-comit e compos e du groupe d'experts d'origine sur ...
Emerging evidence has confirmed that, following administration of a gadolinium-based contrast agent (GBCA), very small amounts of gadolinium will deposit in the brain of humans with intact blood-brain barriers. The literature is evolving rapidly and the degree to which gadolinium will deposit for a particular GBCA or class of GBCAs remains undetermined. Several studies suggest that linear GBCAs deposit more gadolinium in the brain compared with macrocyclic GBCAs; however, our understanding of the molecular composition of deposited gadolinium is preliminary, and the clinical significance of gadolinium deposition remains unknown. To date, there is no conclusive evidence linking gadolinium deposition in the brain with any adverse patient outcome. A panel of radiologists representing the Canadian Association of Radiologists was assembled to assist the Canadian medical imaging community in making informed decisions regarding the issue of gadolinium deposition in the brain. The objectives of the working group were: 1) to review the evidence from animal and human studies; 2) to systematically review existing guidelines and position statements issued by other organizations and health agencies; and 3) to formulate an evidence-based position statement on behalf of the Canadian Association of Radiologists. Based on our appraisal of the evidence and systematic review of 9 guidelines issued by other organizations, the working group established the following consensus statement. GBCA administration should be considered carefully with respect to potential risks and benefits, and only used when required. Standard dosing should be used and repeat administrations should be avoided unless necessary. Gadolinium deposition is one of several issues to consider when prescribing a particular GBCA. Currently there is insufficient evidence to recommend one class of GBCA over another. The panel considered it inappropriate to withhold a linear GBCA if a macrocyclic agent is unavailable, if hepatobiliary phase imaging is required, or if there is a history of severe allergic reaction to a macrocyclic GBCA. Further study in this area is required, and the evidence should be monitored regularly with policy statements updated accordingly.
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