Gadobutrol-enhanced moving-table magnetic resonance angiography in patients with peripheral vascular disease: a prospective, multi-centre blinded comparison with digital subtraction angiography

Abstract

The purpose of this study was to compare moving-table three-dimensional contrast-enhanced magnetic resonance angiography (CE MRA), using 1.0-mol gadobutrol, with intra-arterial digital subtraction angiography (i.a. DSA) for evaluation of pelvic and peripheral arteries in patients with peripheral arterial occlusive disease. A total of 203 patients were examined in a prospective, multi-centre study at 1.0/1.5 T. Ten vessel segments of one leg were evaluated on-site and by three independent blinded reviewers off-site. One hundred eighty-two patients were evaluable in blinded reading. For pelvis and thigh, there was statistically significant diagnostic agreement between CE MRA and i.a. DSA on-site (94%) and off-site (86-88%). Overall, for detection of clinically significant stenoses, 93% sensitivity and 90% specificity were achieved in on-site evaluation, with 71-76 and 87-93% off-site; for detection of occlusion, sensitivity and specificity on-site were 91 and 97%, with 75-82 and 94-98% off-site. Evaluation was more sensitive on-site than off-site for detection of stenoses and occlusion, whereas specificity was similar. The CE MRA with 1.0-mol gadobutrol gave results comparable to those of i.a. DSA for the larger arteries of pelvis and thigh. Results for calf arteries were compromised by spatial resolution and technical limitations.

Intra-individual, randomised comparison of the MRI contrast agents gadobutrol and gadoterate in imaging the distal lower limb of patients with known or suspected osteomyelitis, evaluated in an off-site blinded read

“…It is well known that missing clinical information and a rather artificial presentation of images varying from a radiological routine procedure influence study results towards lower sensitivities and specificities [27][28][29]. Remarkable in our study is the rather low agreement of both readers (slight and in a few cases moderate agreement, Table 4) when assessing qualitative parameters although there had been standardised training sessions for both readers.…”

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

“…Due to its more compact bolus profile, 1.0 M gadobutrol is well suited for dynamic imaging, such as first-pass MR angiography and perfusion imaging [6][7][8][9][10][11][12][13][14]. It is also well suited for standard MRI techniques (e.g., imaging of focal disease in different body regions) with comparable efficacy to other 0.5 M extracellular Gd-chelates, as the concentration of the contrast agent has no impact on the extracellular distribution, including the distribution in lesions.…”

Contrast media in magnetic resonance angiography

“…Most of these contrast agents are based on gadolinium compounds chelated to complicated molecules. Two papers published in this issue of "European Radiology" present the results of multicentric trials on a new 1.0 M Gd preparation [5,6]. While the safety issues of the new compound are thoroughly tested in one study without regard to the clinical value of the investigation, the second paper focuses on the implications of the new CM on peripheral MRA.…”

“…The properties of gadobutrol 1 M for peripheral CE MRA were demonstrated with direct comparison with intra-arterial DSA in the second paper [6]. The aim of that study was to identify the equity of either method for the diagnostic of peripheral arterial occlusive disease.…”