title: Incidence of nephrogenic systemic fibrosis in patients undergoing dialysis after contrast-enhanced magnetic resonance imaging with gadolinium-based contrast agents: the Prospective Fibrose Nephrogénique Systémique study.
abstract: BACKGROUND
  Nephrogenic systemic fibrosis (NSF) has been related to the use of gadolinium-based contrast agents (GBCAs) in patients undergoing dialysis. The Prospective Fibrose Nephrogénique Systémique study, a French prospective study supported by the French drug regulatory agency (Agence Nationale de Sécurité du Médicament) and the French Societies of Nephrology, Dermatology, and Radiology, aimed at determining the incidence of NSF in patients undergoing long-term dialysis.
  
  
  METHODS
  Adult patients undergoing long-term dialysis receiving a magnetic resonance imaging (MRI) examination prescribed between January 15, 2009 and May 31, 2011, with or without GBCA were included. The methodology was based on a patient form intended to detect any dermatological event (DE) that may occur within 4 months after the examination. Further investigations were planned with their physicians if a DE was reported.
  
  
  RESULTS
  A total of 571 patients were included. A total of 50.3% received GBCA. Among them, 93.4% received a macrocyclic GBCA, usually gadoteric acid (88.9%). All in all, 22 patients (3.9%) reported a DE. Dermatological diagnoses did not reveal any evidence of NSF.
  
  
  CONCLUSIONS
  The incidence of NSF after a single dose of a macrocyclic GBCA is null in our sample of 268 patients undergoing dialysis (hemodialysis and peritoneal dialysis). This incidence is just lower than 0.5%. When contrast-enhanced MRI can be essential, or even decisive, to the diagnosis, these results are important and reassuring if physicians need to perform contrast-enhanced MRI in patients undergoing dialysis.
authors.affiliation: From the *Service Information Conseil Adaptation Rénale, Department of Nephrology, Hôpital Pitié-Salpêtrière; †Department of Radiology, Hôpital Européen Georges Pompidou; ‡Department of Dermatology, Hôpital Tenon, Paris; §Department of Pharmacovigilance, Agence Nationale de Sécurité du Médicament, Saint-Denis; ∥Department of Inserm U1018, Hôpital Paul Brousse, Villejuif; ¶Department of Radiology, Hôpital Pontchaillou, Rennes; #Department of Radiology, Hôpital Pellegrin, Bordeaux; **Department of Radiology, Hôpital d'Haguenau, Haguenau; ††Department of Nephrology Dialysis and Transplantation and INSERM 1088, Hôpital Sud, Amiens; ‡‡Department of Nephrology, Hôpital Lyon Sud, Lyon; and §§Department of Nephrology, Hôpital Pitié-Salpêtrière, Paris, France.
authors.forename: Sabine
authors.initials: S
authors.lastname: Amet
authors.forename: Vincent
authors.initials: V
authors.lastname: Launay-Vacher
authors.forename: Olivier
authors.initials: O
authors.lastname: Clément
authors.forename: Camille
authors.initials: C
authors.lastname: Frances
authors.forename: Aurore
authors.initials: A
authors.lastname: Tricotel
authors.forename: Benedicte
authors.initials: B
authors.lastname: Stengel
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Gauvrit
authors.forename: Nicolas
authors.initials: N
authors.lastname: Grenier
authors.forename: Geneviève
authors.initials: G
authors.lastname: Reinhardt
authors.forename: Nicolas
authors.initials: N
authors.lastname: Janus
authors.forename: Gabriel
authors.initials: G
authors.lastname: Choukroun
authors.forename: Maurice
authors.initials: M
authors.lastname: Laville
authors.forename: Gilbert
authors.initials: G
authors.lastname: Deray
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003287:Contrast Media / Q000009:adverse effects; D003956:Dialysis / Q000706:statistics & numerical data*; D005260:Female; D005602:France; D005682:Gadolinium / Q000009:adverse effects*; D006801:Humans; D015994:Incidence; D008279:Magnetic Resonance Imaging / Q000706:statistics & numerical data*; D008297:Male; D008875:Middle Aged; D054989:Nephrogenic Fibrosing Dermopathy / Q000453:epidemiology / Q000209:etiology*; D051436:Renal Insufficiency, Chronic / Q000453:epidemiology / Q000209:etiology* / Q000473:pathology; D012307:Risk Factors
chemical_list: D003287:Contrast Media; D005682:Gadolinium