Using Highly Concentrated Gadobutrol as an MR Contrast Agent in Patients  Also Requiring Hemodialysis

Tombach, Bernd; Bremer, Christoph; Reimer, Peter; Matzkies, F; Schaefer, Roland M.; Ebert, Wolfgang; Geens, Viviane; Eisele, Jeffrey R.; Heindel, Walter

doi:10.2214/ajr.178.1.1780105

Cited by 54 publications

(33 citation statements)

References 30 publications

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“…Maintenance of residual kidney function in dialysis patients may influence the choice of radiologic procedure as well as preprocedure strategies to reduce the risk for contrast-induced acute renal failure. Although magnetic resonance imaging with low dosages of gadolinium was thought to be safe in patients with chronic kidney disease, especially when dialysis was used for poststudy gadolinium removal (37,38), there is some concern that sclerosing fibrosing dermopathy in dialysis patients may be associated with gadolinium (39,40). Postimaging dialysis to remove gadolinium in some patients should perhaps be considered.…”

Section: Imaging Studies In Dialysis Patientsmentioning

confidence: 99%

Screening, Diagnosis, and Treatment of Cancer in Long-Term Dialysis Patients

Holley¹

2007

Clinical Journal of the American Society of Nephrology

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Some have suggested that the American Cancer Society guidelines for cancer screening be applied to patients who are on long-term dialysis and have used cancer screening as a means of assessing delivered preventive health care to patients with ESRD. However, cancer screening is effective only when it leads to survival benefit (usually expressed as days of life saved) without incurring high financial costs. Certain cancers such as human papillomavirus-associated cervical and tongue cancer and urologic malignancies are more common among dialysis patients, yet because the expected remaining lifetime of most dialysis patients is shorter than the time lived to develop malignancy, cancer screening in dialysis patients as applied to the general population is ineffective from the perspective of both cost and survival benefit. Cancer screening in dialysis patients is therefore best provided in an individual patient-focused manner. The occurrence, diagnosis, and treatment of cancer as well as issues related to cancer screening in dialysis patients are discussed.

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Section: Imaging Studies In Dialysis Patientsmentioning

confidence: 99%

Screening, Diagnosis, and Treatment of Cancer in Long-Term Dialysis Patients

Holley¹

2007

Clinical Journal of the American Society of Nephrology

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“…Gadobutrol has shown an excellent renal tolerance in patients suffering from renal impairment or those with end-stage renal failure under hemodialysis treatment [21][22][23]. As of December 2007 there are no reports on NSF in association with the administration of gadobutrol in the peer-reviewed literature.…”

Section: Study Design and Populationmentioning

confidence: 99%

Comparison of 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine-enhanced MRI in 471 patients with known or suspected renal lesions: results of a multicenter, single-blind, interindividual, randomized clinical phase III trial

et al. 2008

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The purpose of this phase III clinical trial was to compare two different extracellular contrast agents, 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine, for magnetic resonance imaging (MRI) in patients with known or suspected focal renal lesions. Using a multicenter, single-blind, interindividual, randomized study design, both contrast agents were compared in a total of 471 patients regarding their diagnostic accuracy, sensitivity, and specificity to correctly classify focal lesions of the kidney. To test for noninferiority the diagnostic accuracy rates for both contrast agents were compared with CT results based on a blinded reading. The average diagnostic accuracy across the three blinded readers ('average reader') was 83.7% for gadobutrol and 87.3% for gadopentate dimeglumine. The increase in accuracy from precontrast to combined precontrast and postcontrast MRI was 8.0% for gadobutrol and 6.9% for gadopentate dimeglumine. Sensitivity of the average reader was 85.2% for gadobutrol and 88.7% for gadopentate dimeglumine. Specificity of the average reader was 82.1% for gadobutrol and 86.1% for gadopentate dimeglumine. In conclusion, this study documents evidence for the noninferiority of a single i.v. bolus injection of 1.0 M gadobutrol compared with 0.5 M gadopentate dimeglumine in the diagnostic assessment of renal lesions with CE-MRI.

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“…According to the study conducted by Yoshikawa and Davies [34], gadoteridol at a dose of 0.3 mmol/kg could be safely administered to patients with end-stage renal disease on dialysis. Tombach et al [39] documented the safety and dialysability of 1-M gadobutrol for doses of 0.1 and 0.3 mmol/kg b.w. in a phase-III clinical trial.…”

Section: Renal Insufficiencymentioning

confidence: 99%

Currently used non-specific extracellular MR contrast media

2003

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Magnetic resonance contrast agents have demonstrated their clinical usefulness in a variety of organs for improved detection of various neoplastic, inflammatory and functional abnormalities. Gadolinium chelates are the most widely used. They are extracellular, non-specific contrast agents. Their use in many clinical indications is justified because, in conjunction with improved imaging techniques, these safe and image-enhancing contrast agents add morphologic and functional information compared with unenhanced MR images. This article describes the commercially available compounds, and summarizes their approval status on the international market regarding indications and doses. Their mechanisms of action, biodistributions, toxicities and tolerance profiles in normal and high-risk patient populations are described. Additionally, this article reviews the specific recommendations by the manufacturers for patients at risk. Finally, their main clinical applications are reviewed.

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Using Highly Concentrated Gadobutrol as an MR Contrast Agent in Patients Also Requiring Hemodialysis

Abstract: Gadobutrol is effectively removed by three hemodialysis sessions using a low-flux polysulfone membrane. Our study documents initial evidence that gadobutrol can be used safely in hemodialysis patients.

Cited by 54 publications

References 30 publications

Screening, Diagnosis, and Treatment of Cancer in Long-Term Dialysis Patients

Screening, Diagnosis, and Treatment of Cancer in Long-Term Dialysis Patients

Comparison of 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine-enhanced MRI in 471 patients with known or suspected renal lesions: results of a multicenter, single-blind, interindividual, randomized clinical phase III trial

Currently used non-specific extracellular MR contrast media

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