{"title":"Clinical trials with iotrolan in myelographic and computed tomography applications in the United States.","authors":"H A Goldstein, D Pfennig","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Iotrolan, a new nonionic contrast agent, was studied in the United States using 190 mg I/ml, 240 mg I/ml, and 300 mg I/ml concentrations. Procedures performed were lumbar, thoracic, cervical, and total columnar myelography and computed tomography applications. Two multicenter double-blind studies (iotrolan versus metrizamide in 190 mg I/ml and 240 mg I/ml concentrations) and five open-label studies were conducted in a total of 863 patients (569 iotrolan, 294 metrizamide). Iotrolan and metrizamide both demonstrated diagnostic efficacy. Iotrolan demonstrated better patient tolerance in comparison with metrizamide.</p>","PeriodicalId":75861,"journal":{"name":"Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin. Erganzungsband","volume":"128 ","pages":"167-70"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13711619","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Iodine-induced hyperthyroidism after contrast media: animal experimental and clinical studies.","authors":"B Steidle","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The healthy thyroid can adapt to an iodine excess in many different ways. The autoregulation mechanisms may, however, fail in a diseased thyroid and severe hyperthyroidism may result. There must be autonomous portions of the thyroid functionally present to cause an iodine-induced hyperthyroidism. Retrospective and prospective studies, as well as animal experiments, were performed to establish further these pathophysiologic mechanisms. It was demonstrated that 15% of all cases of hyperthyroidism can be attributed to the use of iodine-containing contrast media. Furthermore, all contrast media exhibit a deiodinization during their intracorporeal retention time. The most frequent thyroid disorders, usually of a temporary nature, occur after choledochal contrast media. To some extent, these pathophysiologic processes can be reproduced in the animal model. Beyond this, the animal experimental studies show that it is possible to determine functionally autonomous portions of the thyroid by means of a dynamic thyroid scintigraph.</p>","PeriodicalId":75861,"journal":{"name":"Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin. Erganzungsband","volume":"128 ","pages":"6-14"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13712013","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Arterial bolus curve after intravenous injection of ionic and nonionic contrast media.","authors":"E Gmelin, E Rinast, C Ollrogge","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Studies of the intra-arterial bolus curve after intravenous contrast injection with dynamic computed tomography show that a higher bolus maximum can be obtained with a central injection than with a peripheral injection, other injection parameters remaining unchanged. In a singular venous injection ionic and nonionic contrast media show no different effects on the bolus curve. Due to the unfavorable effects of ionic contrast media with high osmolality, for the purposes of intravenous digital substraction angiography nonionic contrast media must be recommended. The subsequent injection of sodium chloride results in a higher bolus maximum.</p>","PeriodicalId":75861,"journal":{"name":"Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin. Erganzungsband","volume":"128 ","pages":"67-9"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13712015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Renal excretion and computed tomography enhancement of iotrolan and iopamidol in dogs.","authors":"G Benness, C Evill, J Wilcox, R Hassam, E Arozoo","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>A comparison of the renal excretion and computed tomography (CT) enhancement of nonionic, monomer and dimer contrast media (CM) (iopamidol and iotrolan) was planned to determine if the latter provides additional and prolonged enhancement in dogs. The excretion studies show almost identical performance of both CM with respect to plasma concentration and renal excretion. However, the lower osmolality of iotrolan permits greater renal concentration in the medulla, papilla, and urine. The potential for this further enhancement of the kidney in CT or urography is marginal.</p>","PeriodicalId":75861,"journal":{"name":"Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin. Erganzungsband","volume":"128 ","pages":"88-90"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13712019","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Pharmacokinetics of iotrolan after intravenous injection into healthy volunteers.","authors":"P Scholz, H J Weinmann, W Mützel, T Staks","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In man Iotrolan is distributed in the extravascular space after intravenous injection with a half-life of about 11 minutes, the elimination half-life being about 108 minutes. After intravenous injection 99.2 +/- 1.8% of the dose was found in the urine and 0.5 +/- 0.1% in the feces within 5 days. No metabolization occurred in man and the pharmacokinetic behavior of iotrolan is comparable to that of known nonionic contrast media (e.g., iohexol, iopromide) (7, 9, 13).</p>","PeriodicalId":75861,"journal":{"name":"Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin. Erganzungsband","volume":"128 ","pages":"211-4"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13712289","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Indirect lymphography with iotrolan.","authors":"H Partsch, C Stöberl, M Wruhs, B I Wenzel-Hora","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Iotrolan was used in concentrations of 240 and 300 mg I/ml for indirect lymphography in a total of 70 patients, and permitted a diagnostic evaluation of the peripheral lymphatics in all cases. The contrast quality was found to correlate with the concentration used. The concentration of 300 mg I/ml Iotrolan was judged to provide the better contrast density and definition. Side effects were limited to transient local erythema and pain during the infusion in one patient and a protracted reaction resembling serum sickness in another patient (Iotrolan 240 mg I/ml). Because of its excellent tolerance, Iotrolan is particularly suitable after subepidermal infusion for indirect lymphography, during which the local lymph drainage of cutaneous regions of interest can be evaluated.</p>","PeriodicalId":75861,"journal":{"name":"Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin. Erganzungsband","volume":"128 ","pages":"178-81"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13712281","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Gastrointestinal diagnosis with iotrolan: experience in pediatric radiology.","authors":"J Tröger, B I Wenzel-Hora","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The use of low-osmolar, nonionic, monomeric contrast media has made gastrointestinal diagnosis with water-soluble contrast media less hazardous with a greater diagnostic yield. Since, however, even this group of compounds is hypertonic in comparison with blood, water is still drawn from the body into the bowel, resulting in water and electrolyte shifts and distal dilution of the contrast material with deterioration of the image quality. The use of iotrolan, which is isotonic in comparison with blood, therefore, appears to offer advantages for selected groups of patients. The superiority of the contrast medium iotrolan over iohexol was demonstrated in a double-blind study. A further 72 examinations in an open-ended study confirmed this result.</p>","PeriodicalId":75861,"journal":{"name":"Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin. Erganzungsband","volume":"128 ","pages":"195-9"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13712284","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Comparative assays of the chemotoxicity of iodinated radiographic contrast media based on impairment of fibrin antithrombin activity.","authors":"B Schulze, H K Beyer","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Radiographic iodized contrast media impair the antithrombin effect of the fibrin clot. The extent of the impairment correlates with dosage and lipophilicity. Normally, 90% of the thrombin activity of 2.3 IU/ml are inactivated by a fibrin clot generated by 2 mg/ml fibrinogen. The effect is due to contrast media-induced protein denaturation with subsequent impairment of thrombin binding to the fibrin clot. Two hepatogenic, two ionic, nephrotopic, and four nonionic contrast media were assayed by this test system at different concentrations. Clear-cut differences were found between the three main groups. Smaller, yet statistically significant, differences could be established between ioglicate and diatrizoate and between iosimide, iopromide or iohexol and iotrolan. No differences were found between iotroxate and iodoxamate. The results are in concordance with the partition coefficients (water/n-butanol) of these contrast media. The assay sensitivity is suitable as a screening system of the chemotoxicity of contrast media. It is easily performed, inexpensive, and assays the clinically important contrast media interaction with fibrinogen.</p>","PeriodicalId":75861,"journal":{"name":"Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin. Erganzungsband","volume":"128 ","pages":"21-3"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13712288","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
T Staks, W Seifert, B I Wenzel-Hora, A Fuhrmeister
{"title":"Organ-specific and general tolerance of iotrolan 280 after intravenous administration: phase I study in healthy volunteers.","authors":"T Staks, W Seifert, B I Wenzel-Hora, A Fuhrmeister","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Iotrolan 280, the first water-soluble, nonionic, blood-isotonic, dimeric contrast medium, was administered intravenously to 12 healthy male volunteers. In a Phase I study with an intraindividual design in comparison with placebo, four doses between 0.15 and a maximum of 0.9 g I/kg body weight were administered in accordance with the principle of dose titration. The highest volume administered was 270.6 ml. The injection rate was 10 ml/min. The observation period was 5 days, with the exception of thyroid parameters (14 days). Iotrolan displayed good general and local tolerance. The typical side effects known from x-ray contrast media either did not occur or were minor after administration of iotrolan. No allergy-like reactions and no effects on hemodynamic parameters were observed. Although one observation is under discussion no effects of iotrolan on impulse generation and propagation in the myocardium could be confirmed. The blood and laboratory and chemical parameters analyzed showed no differences in comparison with placebo. In the treatment group with the highest dose (= 0.9 g I/kg body weight) there was one subject who showed a transient increase of the urinary glucose concentration and one case of a slight transient increase of the serum chloride concentration. No such side effects were seen in the subjects of the treatment groups with lower doses. All renal functions tests were normal. In this study iotrolan showed excellent tolerance after intravenous injection up to 0.9 g I/kg body weight.</p>","PeriodicalId":75861,"journal":{"name":"Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin. Erganzungsband","volume":"128 ","pages":"33-8"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13711484","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Iotrolan, a nonionic dimeric contrast medium in myelography.","authors":"S Bien, M Schumacher, W Berger, B I Wenzel-Hora","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>As part of a clinical Phase III study of the nonionic, dimeric contrast medium iotrolan, differences in opacification, tolerance, and effects on the electroencephalogram after myelography were examined in a double-blind comparison with iohexol. Two groups of 25 patients each received either 10 ml iotrolan 240 mg I/ml or 10 ml iohexol 240 mg I/ml for lumbar myelography, and two groups of 50 patients each received either 10 ml iotrolan 300 mg I/ml or 10 ml iohexol 300 mg I/ml for lumbar, thoracic or cervical myelography. The overall assessment of the opacification in the subarachnoid space, which was moderate in only one case of each group and otherwise good, showed no differences between the preparations. The tolerance of both concentrations of iotrolan proved to be significantly better than those of iohexol: at a significance level in the chi-square test of p less than 0.001 in a simple size of 25 patients per preparation with 240 mg I/ml and at a significance level of p +/- 0.05 in a sample size of 50 patients per preparation with 300 mg I/ml.</p>","PeriodicalId":75861,"journal":{"name":"Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin. Erganzungsband","volume":"128 ","pages":"158-60"},"PeriodicalIF":0.0,"publicationDate":"1989-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"13711616","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}