Prospective cohort study of nephrogenic systemic fibrosis in patients with stage 3-5 chronic kidney disease undergoing mri with injected gadobenate dimeglumine or gadoteridol

Gilles Soulez, Daniel C. Bloomgarden, Neil M. Rofsky, Martin P. Smith, Hani H. Abujudeh, Desiree E. Morgan, Richard J. Lichtenstein, Mark L. Schiebler, Franz J. Wippold, Craig Russo, Matthew J. Kuhn, Kevin W. Mennitt, Jeffrey H. Maki, Alan Stolpen, Johnson Liou, Richard C. Semelka, Miles A. Kirchin, Ningyan Shen, Gianpaolo Pirovano, Alberto Spinazzi

Research output: Contribution to journalArticle

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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 moderateto-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. SUBJECTS AND 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 m2) or stage 4 or 5 CKD (eGFR in cohort 2, <30 mL/min/1.73 m2) 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. CONCLUSION. 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.

Original languageEnglish (US)
Pages (from-to)469-478
Number of pages10
JournalAmerican Journal of Roentgenology
Volume205
Issue number3
DOIs
StatePublished - Sep 1 2015

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Nephrogenic Fibrosing Dermopathy
Chronic Renal Insufficiency
Cohort Studies
Prospective Studies
Gadolinium
Contrast Media
Glomerular Filtration Rate
Signs and Symptoms
Incidence
gadobenic acid
gadoteridol
Physiologic Monitoring
Ambulatory Care
Telephone

Keywords

  • Gadobenate dimeglumine
  • Gadoteridol
  • Nephrogenic systemic fibrosis
  • Prospective studies

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Medicine(all)

Cite this

Prospective cohort study of nephrogenic systemic fibrosis in patients with stage 3-5 chronic kidney disease undergoing mri with injected gadobenate dimeglumine or gadoteridol. / Soulez, Gilles; Bloomgarden, Daniel C.; Rofsky, Neil M.; Smith, Martin P.; Abujudeh, Hani H.; Morgan, Desiree E.; Lichtenstein, Richard J.; Schiebler, Mark L.; Wippold, Franz J.; Russo, Craig; Kuhn, Matthew J.; Mennitt, Kevin W.; Maki, Jeffrey H.; Stolpen, Alan; Liou, Johnson; Semelka, Richard C.; Kirchin, Miles A.; Shen, Ningyan; Pirovano, Gianpaolo; Spinazzi, Alberto.

In: American Journal of Roentgenology, Vol. 205, No. 3, 01.09.2015, p. 469-478.

Research output: Contribution to journalArticle

Soulez, G, Bloomgarden, DC, Rofsky, NM, Smith, MP, Abujudeh, HH, Morgan, DE, Lichtenstein, RJ, Schiebler, ML, Wippold, FJ, Russo, C, Kuhn, MJ, Mennitt, KW, Maki, JH, Stolpen, A, Liou, J, Semelka, RC, Kirchin, MA, Shen, N, Pirovano, G & Spinazzi, A 2015, 'Prospective cohort study of nephrogenic systemic fibrosis in patients with stage 3-5 chronic kidney disease undergoing mri with injected gadobenate dimeglumine or gadoteridol', American Journal of Roentgenology, vol. 205, no. 3, pp. 469-478. https://doi.org/10.2214/AJR.14.14268
Soulez, Gilles ; Bloomgarden, Daniel C. ; Rofsky, Neil M. ; Smith, Martin P. ; Abujudeh, Hani H. ; Morgan, Desiree E. ; Lichtenstein, Richard J. ; Schiebler, Mark L. ; Wippold, Franz J. ; Russo, Craig ; Kuhn, Matthew J. ; Mennitt, Kevin W. ; Maki, Jeffrey H. ; Stolpen, Alan ; Liou, Johnson ; Semelka, Richard C. ; Kirchin, Miles A. ; Shen, Ningyan ; Pirovano, Gianpaolo ; Spinazzi, Alberto. / Prospective cohort study of nephrogenic systemic fibrosis in patients with stage 3-5 chronic kidney disease undergoing mri with injected gadobenate dimeglumine or gadoteridol. In: American Journal of Roentgenology. 2015 ; Vol. 205, No. 3. pp. 469-478.
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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 moderateto-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. SUBJECTS AND 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 m2) or stage 4 or 5 CKD (eGFR in cohort 2, <30 mL/min/1.73 m2) 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. CONCLUSION. 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.",
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T1 - Prospective cohort study of nephrogenic systemic fibrosis in patients with stage 3-5 chronic kidney disease undergoing mri with injected gadobenate dimeglumine or gadoteridol

AU - Soulez, Gilles

AU - Bloomgarden, Daniel C.

AU - Rofsky, Neil M.

AU - Smith, Martin P.

AU - Abujudeh, Hani H.

AU - Morgan, Desiree E.

AU - Lichtenstein, Richard J.

AU - Schiebler, Mark L.

AU - Wippold, Franz J.

AU - Russo, Craig

AU - Kuhn, Matthew J.

AU - Mennitt, Kevin W.

AU - Maki, Jeffrey H.

AU - Stolpen, Alan

AU - Liou, Johnson

AU - Semelka, Richard C.

AU - Kirchin, Miles A.

AU - Shen, Ningyan

AU - Pirovano, Gianpaolo

AU - Spinazzi, Alberto

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N2 - OBJECTIVE. The purpose of this study was to determine the incidence of nephrogenic systemic fibrosis (NSF) in patients with chronic kidney disease (CKD) and moderateto-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. SUBJECTS AND 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 m2) or stage 4 or 5 CKD (eGFR in cohort 2, <30 mL/min/1.73 m2) 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. CONCLUSION. 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.

AB - OBJECTIVE. The purpose of this study was to determine the incidence of nephrogenic systemic fibrosis (NSF) in patients with chronic kidney disease (CKD) and moderateto-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. SUBJECTS AND 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 m2) or stage 4 or 5 CKD (eGFR in cohort 2, <30 mL/min/1.73 m2) 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. CONCLUSION. 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.

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