title: Prospective Cohort Study of Nephrogenic Systemic Fibrosis in Patients With Stage 3-5 Chronic Kidney Disease Undergoing MRI With Injected Gadobenate Dimeglumine or Gadoteridol.
abstract: OBJECTIVE
  The purpose of this study was to determine the incidence of nephrogenic systemic fibrosis (NSF) in patients with chronic kidney disease (CKD) and moderate-to-severe impairment of kidney function who had not previously been exposed to gadolinium-based contrast agents (GBCAs) or referred to undergo contrast-enhanced MRI with gadobenate dimeglumine or gadoteridol.
  
  
  METHODS
  Two multicenter prospective cohort studies evaluated the incidence of unconfounded NSF in patients with stage 3 CKD (estimated glomerular filtration rate [eGFR] in cohort 1, 30-59 mL/min/1.73 m(2)) or stage 4 or 5 CKD (eGFR in cohort 2, < 30 mL/min/1.73 m(2)) after injection of gadobenate dimeglumine (study A) or gadoteridol (study B). A third study (study C) determined the incidence of NSF in patients with stage 4 or 5 CKD who had not received a GBCA in the 10 years before enrollment. Monitoring for signs and symptoms suggestive of NSF was performed via telephone at 1, 3, 6, and 18 months, with clinic visits occurring at 1 and 2 years.
  
  
  RESULTS
  For studies A and B, the populations evaluated for NSF comprised 363 and 171 patients, respectively, with 318 and 159 patients in cohort 1 of each study, respectively, and with 45 and 12 patients in cohort 2, respectively. No signs or symptoms of NSF were reported or detected during the 2 years of patient monitoring. Likewise, no cases of NSF were reported for any of the 405 subjects enrolled in study C.
  
  
  CONCLUSIONS
  To our knowledge, and consistent with reports in the literature, no association of gadobenate dimeglumine or gadoteridol with unconfounded cases of NSF has yet been established. Study data confirm that both gadoteridol and gadobenate dimeglumine properly belong to the class of GBCAs considered to be associated with the lowest risk of NSF.
authors: 1 Centre Hospitalier de l'Université de Montreal-Notre Dame Hospital, Montreal, Canada.
authors: Gilles
authors: G
authors: Soulez
authors: 2 Milwaukee Radiologists Ltd., St. Luke's Medical Center, Milwaukee, WI.|3 Present address: Milwaukee Radiologists Ltd., St. Joseph's Hospital, Milwaukee, WI.
authors: Daniel C
authors: DC
authors: Bloomgarden
authors: 4 Department of Radiology, Beth Israel Deaconess Medical Center, Boston, MA.|5 Present address: Department of Radiology, University of Texas Southwestern Medical Center, Dallas, TX.
authors: Neil M
authors: NM
authors: Rofsky
authors: 4 Department of Radiology, Beth Israel Deaconess Medical Center, Boston, MA.
authors: Martin P
authors: MP
authors: Smith
authors: 6 Department of Radiology, Massachusetts General Hospital, Boston, MA.
authors: Hani H
authors: HH
authors: Abujudeh
authors: 7 Department of Radiology, University of Alabama School of Medicine, Birmingham, AL.
authors: Desiree E
authors: DE
authors: Morgan
authors: 8 Department of Radiology, Sarasota Memorial Hospital, Sarasota, FL.
authors: Richard J
authors: RJ
authors: Lichtenstein
authors: 9 Department of Radiology, University of Wisconsin-Madison School of Medicine and Public Health, Madison, WI.
authors: Mark L
authors: ML
authors: Schiebler
authors: 10 Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, MO.
authors: Franz J
authors: FJ
authors: Wippold
authors: 11 Clinical Radiologists, S.C., Springfield, IL.
authors: Craig
authors: C
authors: Russo
authors: 12 Department of Radiology, St. John's Hospital, Springfield, IL.|13 Present address: Department of Radiology, University of Illinois College of Medicine, Peoria, IL.
authors: Matthew J
authors: MJ
authors: Kuhn
authors: 14 Diagnostic Radiology, Weill Cornell Medical College, New York, NY.
authors: Kevin W
authors: KW
authors: Mennitt
authors: 15 Department of Radiology, Veterans Affairs Puget Sound Health Care System, Seattle, WA.|16 Present address: Department of Radiology, University of Washington Medical Center, Seattle, WA.
authors: Jeffrey H
authors: JH
authors: Maki
authors: 17 Department of Radiology, University of Iowa Hospitals and Clinics, Iowa City, IA.
authors: Alan
authors: A
authors: Stolpen
authors: 18 Radiology Associates of Atlanta, Atlanta, GA.
authors: Johnson
authors: J
authors: Liou
authors: 19 Department of Radiology, University of North Carolina at Chapel Hill, Chapel Hill, NC.
authors: Richard C
authors: RC
authors: Semelka
authors: 20 Bracco Imaging S.p.A, Global Medical and Regulatory Affairs, Via Caduti di Marcinelle 13, Milan 20134, Italy.
authors: Miles A
authors: MA
authors: Kirchin
authors: 21 Bracco Diagnostics Inc., Global Medical and Regulatory Affairs, Monroe Township, NJ.
authors: Ningyan
authors: N
authors: Shen
authors: 21 Bracco Diagnostics Inc., Global Medical and Regulatory Affairs, Monroe Township, NJ.
authors: Gianpaolo
authors: G
authors: Pirovano
authors: 21 Bracco Diagnostics Inc., Global Medical and Regulatory Affairs, Monroe Township, NJ.
authors: Alberto
authors: A
authors: Spinazzi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003287:Contrast Media / Q000009:adverse effects*; D005260:Female; D005682:Gadolinium / Q000009:adverse effects; D006571:Heterocyclic Compounds / Q000009:adverse effects*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications*; D007677:Kidney Function Tests; D008279:Magnetic Resonance Imaging; D008297:Male; D008536:Meglumine / Q000009:adverse effects / Q000031:analogs & derivatives*; D008875:Middle Aged; D054989:Nephrogenic Fibrosing Dermopathy / Q000139:chemically induced* / Q000453:epidemiology; D009942:Organometallic Compounds / Q000009:adverse effects*; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D012307:Risk Factors
chemical_list: D003287:Contrast Media; D006571:Heterocyclic Compounds; D009942:Organometallic Compounds; C062402:gadoteridol; C064572:gadobenic acid; D008536:Meglumine; D005682:Gadolinium
keywords: gadobenate dimeglumine; gadoteridol; nephrogenic systemic fibrosis; prospective studies