Sicherheit und Nutzen von Gadobutrol bei Patienten mit zerebralen Tumoren (Phase-III-Studie)

Abstract

For the differentiation of primary brain tumours the single dose was sufficient, in metastatic lesions triple dose was essential for the detection or exclusion of multifocality.

Value of 1.0-M gadolinium chelates: review of preclinical and clinical data on gadobutrol

“…was sufficient for differentiation of primary brain tumors in clinical practice, but a dose of 0.3 mmol/kg b.w. was essential for the detection or exclusion of multifocality for brain metastasis [21]. These data are confirmed by another clinical study with single-(0.1 mmol/kg b.w.)…”

“…on differentiation of primary brain tumors and detection rate of cerebral metastasis [21]. The authors concluded that a dose of 0.1 mmol/kg b.w.…”

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

“…Gadobutrol and gadoterate have been successfully tested in both animal and human studies for safety and diagnostic reliability [8][9][10][11][12][13][14][15]. In Europe, gadobutrol is currently approved for contrast enhancement in cranial and spinal MRI, MR Angiography and MRI of the liver and kidneys.…”

Diagnostic Yield of Double-Dose Gadobutrol in the Detection of Brain Metastasis: Intraindividual Comparison with Double-Dose Gadopentetate Dimeglumine

“…18 Higher dose administration is known to be more effective in lesion detection, but consideration must be given to reducing the amount of gadolinium administered to the patient because of the risk of contrast-related reactions and nephrogenic systemic fibrosis. 19,20 Gadobutrol had been proved to be a safe MR imaging contrast agent in patients with impaired renal function at doses of Յ0.3 mmol/L/kg of weight, 18 and no nephrogenic systemic fibrosis has been reported so far. 17 At this point, we can postulate that DD gadobutrol is expected to offer better opportunity for further improved enhancement than other Gd contrast agents because of the higher T1 relaxation effect.…”