title: Ferucarbotran (Resovist): a new clinically approved RES-specific contrast agent for contrast-enhanced MRI of the liver: properties, clinical development, and applications.
abstract: Ferucarbotran (Resovist) is the second clinically approved superparamagnetic iron oxide developed for contrast-enhanced MRI of the liver. The purpose of this review is to provide an overview on the properties, clinical development, and application of ferucarbotran. Safety data obtained during clinical phases I-III revealed a total of 162 adverse events within 1053 patients, of which 75 were classified as possibly, probably, or definitely drug related. The majority of events occurred within the first 3 h (73 of 75) and was of mild intensity. The agent significantly improves the detection of hypovascular focal liver lesions with a comparable sensitivity in lesion detection to CTAP but without a relevant loss in specificity. Furthermore, ferucarbotran leads to a significant improvement of the sensitivity for lesion classification and characterization of the most frequent liver lesions. Contrast-enhanced MRA is not feasible and the angiographic effect is not sufficient to allow for postprocessing of data into maximum intensity projections. Intraindividual studies at low-field (0.2 T) and high-field (1.5 T) showed similar rates for lesion detection. The time window for contrast-enhanced MRI of the liver is at least 1 day up to 4 days. The compound can be regarded as safe and well tolerated. Even bolus injections caused no cardiovascular side effects, lumbar back pain, or clinically relevant laboratory changes. The examination time can be kept short with T1- and T2-weighted pre-contrast sequences, dynamic MRI over 10 min, and finally accumulation phase T2-weighted MRI. Patients who may benefit in particular are surgical candidates for resection, transplantation, or interventional therapies, and patients with liver cirrhosis and/or suspected hepatocellular carcinoma to either exclude malignancy or to define the extent of disease, the location of lesions, and the type of newly detected lesions.
authors.affiliation: Department of Radiology, Städtisches Klinikum Karlsruhe, Moltkestrasse 90, 76133 Karlsruhe, Germany. p.reimer@web.de
authors.forename: Peter
authors.initials: P
authors.lastname: Reimer
authors.forename: Thomas
authors.initials: T
authors.lastname: Balzer
mesh_terms: D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D003287:Contrast Media / Q000009:adverse effects; D003911:Dextrans; D052203:Ferrosoferric Oxide; D006801:Humans; D007501:Iron / Q000009:adverse effects; D008099:Liver / Q000473:pathology*; D008107:Liver Diseases / Q000175:diagnosis*; D008113:Liver Neoplasms / Q000175:diagnosis; D018810:Magnetic Resonance Angiography; D008279:Magnetic Resonance Imaging; D058185:Magnetite Nanoparticles; D015337:Multicenter Studies as Topic; D010087:Oxides / Q000009:adverse effects; D016032:Randomized Controlled Trials as Topic; D012449:Safety; D013997:Time Factors
chemical_list: D003287:Contrast Media; D003911:Dextrans; D058185:Magnetite Nanoparticles; D010087:Oxides; D007501:Iron; C065507:ferumoxides; D052203:Ferrosoferric Oxide