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Bad Homburg vor der Höhe, Germany

Schneider G.,Homburg University Hospital | Schurholz H.,Homburg University Hospital | Kirchin M.A.,Bracco Imaging Spa | Bucker A.,Homburg University Hospital | Fries P.,Homburg University Hospital
Pediatric Radiology | Year: 2013

Background: Gadolinium-based MR contrast agents have long been considered safe for routine diagnostic imaging. However, the advent of nephrogenic systemic fibrosis (NSF) among certain patients with severe renal insufficiency has brought the issue of safety into question. Nowhere is safety of greater concern than among children who frequently require multiple contrast-enhanced MRI examinations over an extended period of time. Objective: To retrospectively evaluate the safety of gadobenate dimeglumine for contrast-enhanced (CE) MRI across a range of indications. Materials and methods: Two hundred pediatric inpatients (age: 4 days to 15 years) underwent CE MRI as part of clinical routine. The children received a gadobenate dimeglumine dose of either 0.05 mmol/kg body weight (liver, abdominal imaging, musculoskeletal imaging, brain and other rare indications) or 0.1 mmol/kg bodyweight (cardiovascular imaging, MR-urography). Young (< 8 years) children with congenital heart disease were intubated and underwent MRA evaluation with controlled ventilation. Monitoring for adverse events was performed for at least 24 h after each gadobenate dimeglumine injection. Depending on clinical necessity, laboratory measurements and, in some cases, vital sign and ECG determinations were made before and after contrast injection. Safety was evaluated by age group, indication and dose administered. Results: No clinically adverse events were reported among children who had one MRI scan only or among children who had several examinations. There were no changes in creatinine or bilirubin levels even in very young children. Conclusions: No adverse events were recorded during the first 24 h following administration of gadobenate dimeglumine in 200 children. © 2012 Springer-Verlag.

Seidl Z.,Lekarska Fakulta | Vymazal J.,Na Homolce Hospital | Mechl M.,University Hospital Brno | Goyal M.,Seaman Family Center | And 11 more authors.
American Journal of Neuroradiology | Year: 2012

BACKGROUND AND PURPOSE: Gadobenate dimeglumine has proved advantageous compared with other gadolinium-based contrast agents for contrast-enhanced brain MR imaging. Gadobutrol is a more highly concentrated agent (1.0 mol/L). This study intraindividually compared 0.1-mmol/kg doses of these agents for qualitative and quantitative evaluation of brain tumors. MATERIALS AND METHODS: Adult patients with suspected or known brain tumors underwent 2 identical MR imaging examinations at 1.5T, 1 with gadobenate dimeglumine and the other with gadobutrol, both at a dose of 0.1-mmol/kg body weight. The agents were injected in randomized order separated by 3-14 days. Imaging sequences and acquisition timing were identical for the 2 examinations. Three blinded readers evaluated images qualitatively for diagnostic information (lesion extent, delineation, morphology, enhancement, global preference) and quantitatively for CNR and LBR. RESULTS: One hundred fourteen of 123 enrolled patients successfully underwent both examinations. Final diagnoses were intra-axial tumors, metastases, extra-axial tumors, "other" tumors, and "nontumor" (49, 46, 8, 7, and 4 subjects, respectively). Readers 1, 2, and 3 demonstrated preference for gadobenate dimeglumine in 46 (40.7%), 54 (47.4%), and 49 (43.0%) patients, respectively, compared with 6, 7, and 7 patients for gadobutrol (P < .0001, all readers). Highly significant (P < .0001, all readers) preference for gadobenate dimeglumine was demonstrated for all other qualitative end points. Inter-reader agreement was good for all evaluations (κ = 0.414-0.629). Significantly superior CNR and LBR were determined for gadobenate dimeglumine (P < .019, all readers). CONCLUSIONS: Significantly greater morphologic information and lesion enhancement are achieved on brain MR imaging with 0.1-mmol/kg gadobenate dimeglumine compared with gadobutrol at an equivalent dose.

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