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

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

Comparison between a linear versus a macrocyclic contrast agent for whole body MR angiography in a clinical routine setting

<p>Abstract</p> <p>Background</p> <p>Previous experiences of whole body MR angiography are predominantly available in linear 0.5 M gadolinium-containing contrast agents. The aim of this study was to compare image quality on a four-point scale (range 1–4) and diagnostic accuracy of a 1.0 M macrocyclic contrast agent (gadobutrol, n = 80 patients) with a 0.5 M linear contrast agent (gadopentetate dimeglumine, n = 85 patients) on a 1.5 T whole body MR system. Digital subtraction angiography served as standard of reference.</p> <p>Results</p> <p>All examinations yielded diagnostic image quality. There was no significant difference in image quality (3.76 ± 0.3 versus 3.78 ± 0.3, p = n.s.) and diagnostic accuracy observed. Sensitivity and specificity of the detection of hemodynamically relevant stenoses was 93%/95% in the gadopentetate dimeglumine group and 94%/94% in the gadobutrol group, respectively.</p> <p>Conclusion</p> <p>The high diagnostic accuracy of gadobutrol in the clinical routine setting is of high interest as medical authorities (e.g. the European Agency for the Evaluation of Medicinal Products) recommend macrocyclic contrast agents especially to be used in patients with renal failure or dialysis.</p

Quantitative analysis of late gadolinium enhancement in hypertrophic cardiomyopathy: comparison of diagnostic performance in myocardial fibrosis between gadobutrol and gadopentetate dimeglumine

The purpose of this study was to compare different semi-automated late gadolinium enhancement (LGE) quantification techniques using gadobutrol and gadopentetate dimeglumine contrast agents with regard to the diagnosis of fibrotic myocardium in patients with hypertrophic cardiomyopathy (HCM). Thirty patients with HCM underwent two cardiac MRI protocols with use of gadobutrol and gadopentetate dimeglumine. Contrast-tonoise ratio (CNR) between LGE area and remote myocardium (CNRremote), between LGE area and left ventricular blood pool (CNRpool), and signal-to-noise ratio (SNR) in LGE were compared. The presence and quantity of LGE were determined by visual assessment. With signal threshold versus reference mean (STRM) based thresholds of 2 SD, 5 SD, and 6 SD above the mean signal intensity (SI) of reference myocardium, the full-width at half-maximum (FWHM) technique was used. The volume and segments of the LGE area were compared between the two types of contrast agents. LGE was present in 26 of 30 (86.6%) patients in both protocols. The CNRremote of fibrotic myocardium in gadobutrol and gadopentetate dimeglumine agents was 26.82 ± 14.24 and 21.46 ± 10.59, respectively (P &lt; 0.05). The CNRpool was significantly higher in gadobutrol (9.32 ± 7.64 vs. 6.39 ± 6.11, P &lt; 0.05). The SNR was higher in gadobutrol (33.36 ± 14.35 vs. 27.53 ± 10.91, P &lt; 0.05). The volume of scar size in MR images acquired with gadobutrol were significantly higher than those with gadopentetate dimeglumine (P &lt; 0.05), and the STRM of 5 SD technique showed the greatest agreement with visual assessment (ICC = 0.99) in both examinations. There was no significant difference in fibrotic segments of the fibrotic myocardium in the LGE area (P &lt; 0.05). This study proved that the Gadobutrol was an effective contrast agent for LGE imaging with superior delineation of fibrotic myocardium as compared to gadopentetate dimeglumine. The 5 SD technique yields the closest approximation of the extent of LGE identified by visual assessment

Imaging in the time of NFD/NSF: do we have to change our routines concerning renal insufficiency?

To date there are potential chronology-based but not conclusive reasons to believe that at least some of the gadolinium complexes play a causative role in the pathophysiology of nephrogenic systemic fibrosis (NSF) or nephrogenic fibrosing dermopathy (NFD). Still, the exact pathogenesis and the risk for patients is unclear beside the obvious connection to moderate to severe renal insufficiency. So far, MR imaging with Gd-enhancement was regarded as the safest imaging modality in these patients—the recent development creates tremendous uncertainty in the MR-community. Nevertheless, one should remember that, despite the over 200 cases of NSF and about 100 with proven involvement of Gd3+, the vast majority of over 200 million patients exposed to gadolinium since the 1980s have tolerated these agents well. Importantly, NSF is a rare disease and does not appear to occur in patients without renal impairment. Many patients and researchers have undergone MR investigations with Gd exposure in the past. For those, it is essential to know about the safety of the agents at normal renal function. We can hope that pharmacoepidemiological and preclinical studies will allow us to better understand the pathophysiology and role of the various MR contrast agents in the near future

Case-Report: Autonierentransplantation nach Nierenarterienaneurysma-Stenting

Jimmy Murphy's Albion box lorry photographed 23 May 1964. Digitisation and record funded by the Pilgrim Trust