Acta radiologica. Supplementum最新文献

Purpose: The purpose of this double-blind, randomized parallel trial was to evaluate and compare the clinical safety and the diagnostic efficacy of the new nonionic triiodinated contrast agent iobitridol (300 mg I/ml) with those of iohexol (300 mg I/ml) in CT examinations in children.

Material and methods: Eighty children of either sex were included in the study. Of those, 40 patients received iobitridol, 40 iohexol. Mean volume injected i.v. was 1.8 ml/kg b.w. Adverse reactions occurring during 24 hours after the injection of the contrast agent were recorded.

Results: Image quality was judged good or excellent in all study examinations and all were diagnostically informative. There was no significant difference in clinical safety between the 2 groups and only adverse reactions of mild or moderate intensity were reported in both groups.

Conclusion: Iobitridol appears to be a safe, well tolerated and effective contrast agent, when used for brain and body CT in children.

Purpose: The toxicologic profile of iobitridol, a new nonionic low-osomolality contrast medium, was evaluated in compliance with the current regulatory requirements in Europe, the USA and Canada.

Material and methods: The toxicity of iobitridol was tested following acute or repeated i.v. administration in several different species (mouse, rat, dog); single oral administration in the mouse and intracisternal injection in the rat. Furthermore, teratogenicity and mutagenicity were evaluated in the rat and rabbit. Local perivenous toxicity was assessed in the rabbit.

Results: The acute toxicity of iobitridol in the mouse is equivalent to that of iohexol, a reference product tested under the same conditions. Chronic administration (daily injections i.v. injection over 4 weeks) in the rat and dog did not demonstrate any particular toxicity for iobitridol. It should be noted that, unlike iohexol, iobitridol did not provoke any vacuolization of the renal tubular cells in the rat following repeated injections. Furthermore, this contrast agent did not show any teratogenic or mutagenic potential. The typical local inflammatory signs observed following perivenous injection in the rabbit were low in intensity and reversible.

Conclusion: The toxicologic profile of iobitridol appears to be favorable and does not show any particular risk for clinical use under the usual indications of water soluble iodinated contrast agents.

Purpose: The efficacy and adverse reactions of iobitridol versus iohexol in contrast-enhanced CT (CECT) of the head were investigated.

Material and methods: This double-blind randomized parallel study compared the clinical and biological safety of iobitridol and iohexol (350 mgI/ml), administered intravenously (1 ml/kg) to 276 patients undergoing CECT of the head. Vital signs were assessed just before after injection, and 24 hours after. A biologic examination was performed before and after injection. Both groups were comparable at inclusion.

Results and conclusion: The within-group variation for vital signs after injection and 24 hours after was not clinically relevant and no significant difference was evident between treatment groups. The incidence of adverse events was similar in both groups (11.0% for iobitridol and 7.1 % for iohexol), consisting most often of a sensation of warmth. Biologic parameters remained stable and did not differ significantly between groups. The quality of imaging was rated good or excellent in 70% of cases and a very high diagnostic discrimination was achieved (98%). Iobitridol compared favorably with iohexol for head CECT.

The present article combines and summarizes the preclinic studies carried out in vitro and in vivo to determine the pharmacologic and biochemical profile of iobitridol, a new nonionic iodinated low-osmolality contrast medium (CM). The effects of this product on the main hemodynamic, bronchopulmonary, neurologic, renal, blood chemistry and electrophysiologic parameters and RBC morphology were studied in detail in comparison with CM in the same chemical category or with reference substances of the same osmolality. The in vivo studies were performed under conditions resembling clinical use. Iobitridol showed an excellent pharmacologic and biochemical profile, which was identical or superior to that of other products in its category.

Purpose: Evaluation of imaging quality and safety of iobitridol 300 compared to iohexol 300 in urography.

Materials and methods: 180 patients were included in an urography multicenter study (3 centers, 60 patients in each).

Results: There was no significant difference in either the imaging quality or the clinical safety between the 2 contrast media groups.

Conclusion: Iobitridol is a safe and efficient contrast agent in urography.

Iobitridol 250 (Xenetix 250) was compared with iohexol 240 (Omnipaque 240) in phlebography of the lower limbs by means of a multicenter, randomized double-blind trial in 70 patients. No significant difference was demonstrated between the 2 groups in terms of diagnostic efficacy, image quality or clinical safety. Only minor reactions were recorded in the 2 groups, essentially consisting of mild or moderate heat sensations. The only insufficiently informative examinations were not due to the contrast agent. Iobitridol 250 therefore appears to be a well-tolerated contrast medium, suitable for use in phlebography of the lower limbs.

Purpose: A new nonionic low-osmolality contrast medium, iobitridol (Xenetix 350) was compared with iohexol (Omnipaque) after i.v. injection in anesthetized rabbits to assess efficacy in CT examinations and biodistribution.

Material and methods: The densities in test tubes and the pharmacogenetics and biodistribution of iobitridol 350 and iohexol were compared in rabbits. CT of the brain, liver, the abdominal aorta and the kidneys was performed before and after injection of the contrast media.

Results: In aqueous medium, iobitridol absorbed roentgen rays in a manner exactly identical to that of iohexol. Within 15 min following injection of iohexol and iobitridol at a dose of 300 mg I/kg, both contrast agents resulted in aortic enhancement which decreased with time. An increased attenuation of the liver also occurred, decreasing with time. There was no significant enhancement in the brain but enhancement was found in the renal pelvocalyceal cavities 10 min postinjection. No significant difference was found between the 2 contrast agents under the study conditions.

Conclusion: As could be expected from its behavior as a tracer of extracellular fluid, iobitridol resulted in significant changes in the signal, corresponding to its vascular, hepatic and renal pharmacokinetics in rabbits.

Variations in the size and shape of the human vestibular aqueduct were evaluated in 118 plastic casts of unselected specimens of human temporal bones. They were examined by conventional radiography and by high resolution CT. The degree of the mastoid and perilabyrinthine pneumatization was defined and classified into 3 types. The dimensions of the peripheral portion of the aqueduct were found to be related to the extent of the perilabyrinthine pneumatization.

Purpose: The diagnostic efficacy and the clinical tolerance of iobitridol 300 was evaluated in 68 patients receiving intraarterial injection in 2 monocentric comparative randomized double-blind trials with iopromide 300 (30 patients) and iopamidol 300 (40 patients) as reference. RESULTS; There is no significant difference in quality of opacification or in diagnostic efficacy between the products in each trial. No major adverse reactions occurred after the injection of iobitridol 300. Excluding a heat sensation, 5 of the patients who received iobitridol had minor reactions consisting of nausea with vomiting and pain during the injection. Five patients in the reference group also experienced adverse events.

Conclusion: Iobitridol is well tolerated after intraarterial administration and it has the same diagnostic quality as iopromide and iopamidol.