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

Pennekamp, Werner; Roggenland, D.; Hering, S.; Lemburg, Stefan P.; Peters, Sören; Sterl, Sabrina; Schwenke, Carsten; Nicolas, Volkmar

doi:10.1007/s00330-010-2008-z

Cited by 7 publications

(8 citation statements)

References 28 publications

(27 reference statements)

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“…The results presented here support previous findings where gadobutrol 1.0 M combined contrastenhanced MRI was effective for the detection and visualization of CNS lesions (12,15,16), as well as lesions elsewhere in the body (5,18,20,21,(23)(24)(25)(26)(27)(28).…”

Section: Discussionsupporting

confidence: 90%

“…The efficacy of gadobutrol in MRI of the central nervous system (CNS), together with its physicochemical properties and safety profile, have been extensively studied . Moreover, further studies have shown that gadobutrol 1.0 M is also effective in the MRI of other body regions, including prostate carcinomas , MR angiography , limb osteomyelitis , liver , breast , cardiac tissue , and the kidney .…”

mentioning

confidence: 99%

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A multicenter, randomized, controlled, single‐blind comparison phase III study to determine the efficacy and safety of gadobutrol 1.0 M versus gadopentetate dimeglumine following single injection in patients referred for contrast‐enhanced MRI of the body regions or extremities

Kuwatsuru

Takahashi

Umeoka

et al. 2014

Magnetic Resonance Imaging

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Purpose To demonstrate the noninferiority of gadobutrol‐enhanced magnetic resonance imaging (MRI) compared with gadopentetate dimeglumine‐enhanced MRI in Asian patients referred for contrast‐enhanced imaging of the body or extremities. Materials and Methods A multicenter, parallel‐group comparison study of Asian adults referred for contrast‐enhanced MRI were randomized (1:1) to either gadobutrol or gadopentetate dimeglumine. Lesions were assessed for three primary visualization variables: degree of contrast enhancement, border delineation, and internal morphology. Secondary efficacy variables included number of lesions detected, match of MRI diagnosis with final clinical diagnosis, and sensitivity and specificity for malignant lesion detection. Safety was monitored for 24 ± 4 hours after contrast agent administration. Results A total of 363 patients received either gadobutrol (n = 168) or gadopentetate dimeglumine (n = 178). Mean total scores for three primary visualization variables were 9.39 and 9.34 for gadobutrol and gadopentetate dimeglumine, respectively. The proportion of patients with matched MRI and final diagnosis and sensitivity for malignant lesion detection was greater for unenhanced versus combined images (gadobutrol: 72.2% vs. 81.7%; gadopentetate dimeglumine: 76.2% vs. 82.2%, respectively). Both contrast agents were well tolerated. Conclusion Gadobutrol (0.1 mmol/kg BW) was well tolerated and effective in Asian patients referred for contrast‐enhanced MRI of the body or extremities. J. Magn. Reson. Imaging 2014. © 2014 Wiley Periodicals, Inc. J. Magn. Reson. Imaging 2015;41:404–413.© 2013 Wiley Periodicals, Inc.

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Section: Discussionsupporting

confidence: 90%

mentioning

confidence: 99%

A multicenter, randomized, controlled, single‐blind comparison phase III study to determine the efficacy and safety of gadobutrol 1.0 M versus gadopentetate dimeglumine following single injection in patients referred for contrast‐enhanced MRI of the body regions or extremities

Kuwatsuru

Takahashi

Umeoka

et al. 2014

Magnetic Resonance Imaging

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“…Regarding enhancement characteristics, only the study on hepatocellular carcinoma using a double dose of gadobutrol showed superiority of the 1.0 M GBCA in terms of SNR and CNR (16). The other studies either did not measure SNR or CNR (14,15), or showed equivalence between the two products (18).…”

Section: Resultsmentioning

confidence: 99%

“…1). Seven studies dealt with magnetic resonance angiography (MRA) (4–10), three with cardiac MRI (11–13), six with soft tissue neoplastic and inflammatory lesion (STL) MRI (14–19), and five with central nervous system (CNS) MRI (20–24). All studies were published between March 2005 and July 2013 and are representative of the clinical practice in CE-MRI.…”

Section: Methodsmentioning

confidence: 99%

Effects of gadolinium-based contrast agent concentrations (0.5 M or 1.0 M) on the diagnostic performance of magnetic resonance imaging examinations: systematic review of the literature

Lancelot

Froehlich

Heine³

et al. 2016

Acta Radiol

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Background To date there is no agreement as to what is the optimal concentration for gadolinium-based contrast agents (GBCAs). Purpose To assess whether diagnostic performance differences exist between 0.5 M and 1.0 M GBCAs used for magnetic resonance imaging (MRI). Material and Methods A PubMed literature search identified 21 clinical studies published between 2005 and 2013 which evaluated the diagnostic efficacy of both types of GBCAs. Study design, type of procedure, GBCA administration mode, imaging performances, impact on patient management, study limitations, and biases were analyzed. No statistical test was performed on pooled data. Results Sixteen comparative and five non-comparative studies were analyzed, involving 2183 patients who underwent MRI procedures for various indications. In 67% of the studies, 0.5 M and 1.0 M GBCAs were injected at equimolar gadolinium amounts per kg body weight. Only 33% applied the same molar flow rate for delivery of the GBCAs. No significant differences between GBCAs were reported for 23 out of 27 qualitative endpoints (mainly image quality, lesion, and vessel visualization) and 29 out of 40 quantitative endpoints. Three out of four studies with non-equimolar delivery rates showed better contrast-to-noise and signal-to-noise ratios for 1.0 M gadobutrol, without showing an impact on diagnostic performance. Methodological biases were identified in several studies impairing the interpretation of comparisons. Conclusion Imaging differences between 0.5 M and 1.0 M GBCAs were essentially observed under non-equimolar delivery rates. However, they did not result into greater diagnostic efficacy when performed under equimolar conditions.

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“…In this phase, HC-GBCAs do not provide superior enhancement compared with C-GBCAs at an equivalent dose of 0.1 mmol/kg body weight [ 38 ] . No comparisons have been made between HR-GBCA and C-GBCA or HC-GBCA.…”

Section: Clinical Applicationsmentioning

confidence: 99%

Use of contrast agents in oncological imaging: magnetic resonance imaging

Morana¹,

Cugini²,

Scatto³

et al. 2013

Cancer Imaging

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Magnetic resonance plays a leading role in the management of oncology patients, providing superior contrast resolution and greater sensitivity compared with other techniques, which enables more accurate tumor identification, characterization and staging. Contrast agents are widely used in clinical magnetic resonance imaging; approximately 40–50% of clinical scans are contrast enhanced. Most contrast agents are based on the paramagnetic gadolinium ion Gd3+, which is chelated to avoid the toxic effects of free gadolinium. Multiple factors such as molecule structure, molecule concentration, dose, field strength and temperature determine the longitudinal and transverse relaxation rates (R1 and R2, respectively) and thus the T1- and T2-relaxivities of these chelates. These T1- and T2-relaxivities, together with their pharmacokinetic properties (i.e. distribution and concentration in the area of interest), determine the radiologic efficacy of the gadolinium-based contrast agents.

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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

Cited by 7 publications

References 28 publications

A multicenter, randomized, controlled, single‐blind comparison phase III study to determine the efficacy and safety of gadobutrol 1.0 M versus gadopentetate dimeglumine following single injection in patients referred for contrast‐enhanced MRI of the body regions or extremities

A multicenter, randomized, controlled, single‐blind comparison phase III study to determine the efficacy and safety of gadobutrol 1.0 M versus gadopentetate dimeglumine following single injection in patients referred for contrast‐enhanced MRI of the body regions or extremities

Effects of gadolinium-based contrast agent concentrations (0.5 M or 1.0 M) on the diagnostic performance of magnetic resonance imaging examinations: systematic review of the literature

Use of contrast agents in oncological imaging: magnetic resonance imaging

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