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Overview on the Efficacy and Safety of Gadobutrol: an MRI Contrast Agent for the CNS, Body and Vessels

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Overview on the Efficacy and Safety of Gadobutrol: an MRI Contrast Agent for the CNS, Body and Vessels CONTRAST AGENT EVALUATION Overview on the efficacy and safety of gadobutrol: an MRI contrast agent for the CNS, body and vessels Contrast-enhanced MRI has become a mainstay of clinical imaging with unlimited applications. However, a limitation of conventional contrast agents in MRI is the insufficient signal-to-noise ratios due to relaxivity. Gadobutrol (1.0 mmol/ml), an extracellular macrocyclic contrast agent of high stability, is indicated for contrast-enhanced MRI of adults, adolescents and children 2 years of age and older. Gadobutrol offers increased T1 relaxivity, which improves MR image quality and clinical use of the technique. 1 KEYWORDS: contrast-enhanced MRA n contrast-enhanced MRI n CNS n Gadavist™ Juan E Gutierrez* , n gadobutrol n gadolinium-based contrast agent n Gadovist™ n kidney n liver Sara Koenig1 & Josy Breuer2 The use of gadolinium-based contrast agents As with other GBCAs, the paramagnetic 1University of Texas at San Antonio, (GBCAs) to improve MRI has been well qualities of the gadolinium ion shortens the Health Science Center 7703 Floyd Curl Drive, San Antonio, TX 78229-3900, established for over 20 years [1,2]. Unenhanced T1 relaxation times of nearby water protons USA MRI of the CNS, abdomen/pelvis, breast and and results in increased signal on T -weighted 2Bayer-Schering AG, Berlin, Germany 1 *Author for correspondence: vascular system has mainly been used to dis- images improving the lesion detection (sensitiv- Tel.: +1 210 567 1978 play/demarcate focal pathologies or areas of ity), characterization (specificity) and staging. Fax: +1 210 567 6464 stenosis; however, GBCAs have improved the Besides the registered trade name (GADAVIST® [email protected] detection, characterization and visualization of Injection, USA and GADOVIST®, in the rest lesions involved in such pathologies, improving of the world, the generic name (gadobutrol) the diagnostic work-up, therapy planning and and the laboratory nomenclature (Gd-DO3A- monitoring evolution after therapeutic inter- butriol or ZK 135079) have been used in some ventions [3]. Thus, when any lesion located in publications. Due to the unique physico- this body area are clinically suspected, com- chemical qualities of gadobutrol, solutions of bined MRI with and without GBCAs is the 1.0 M concentration of Gd can be prepared. best method for defining lesion characteristics. This concentration is twice that of all other Gadobutrol is a nonionic, macrocyclic, extra- extra cellular MRI contrast media currently cellular MRI contrast agent. Like gadopentetate marketed (0.5 M). dimeglumine (MAGNEVIST® Bayer-Schering, At the same dose as 0.5 M agents, injected Berlin, Germany) and other extracellular MRI intravenously at the same rate, the 1.0 M con- contrast agents, gadobutrol contains gado- centration results in higher first-pass concen- 3+ linium ions (Gd; Gd ). Gadolinium is a rare trations than a 0.5 M formulation [6]. In brain earth element that causes contrast enhancement perfusion MRI, these improved bolus charac- in MRI scans. Gadobutrol is the active ingre- teristics of 1.0 M gadobutrol were studied to dient, it is a paramagnetic gadolinium chelate evaluate the differences in contrast between with low osmolarity and viscosity, and high ischemic and nonischemic tissue as compared paramagnetic effect (relaxivity) [4], the Gd is with the 0.5 M concentration at the same tightly bound in a macrocyclic complex with a dose [7]. Furthermore, gadobutrol is known to high stability. The relevant stability parameter provide similar imaging properties in conven- for macrocyclic contrast agents in contrast to tional contrast-enhanced MRI (CE-MRI) of open-chain GBCAs is kinetic stability instead various body regions other than the CNS, as is of thermodynamics. A study in 2006 exam- the case with other approved contrast agents. ined the stability of different compounds by Gadobutrol is suitable for all clinically used using possible transmetallation by zinc ions MRI sequences (e.g., imaging of focal disease and calculated a so-called ‘long time index’ in different body regions) without the need to and ‘ratio index’. The ratio index, for example, modify the parameters used with other GBCAs, showed a decomplexation of less than 10% after as the concentration of the contrast agent has 5000 min, compared with 70–600 min for the no significant impact on the extracellular dis- open-chain compounds [5]. tribution including the distribution in lesions. part of 10.2217/IIM.11.70 © 2012 Future Medicine Ltd Imaging Med. (2012) 4(1), 25–40 ISSN 1755-5191 25 CONTRAST AGENT EVALUATION Gutierrez, Koenig & Breuer O to detect or exclude a disease has been docu- O mented by their approval for imaging areas all over the body. The contribution of a CE-MRI -O O- is commonly accepted in the medical–scien- N N tific community. It can lead to a change in the 3+ diagnostic work-up, differential diagnosis and GdGd patient management [6,7,10]. The first approval of a GBCA occured in 1988 and has since led N N to the performance of more than 160 million -O H H OH CE-MRI examinations worldwide. Advances in hardware and software have O OH created additional needs regarding high relax- ivity and/or small volumes of MRI contrast OH media, especially in perfusion MRI and MRA Figure 1. Gadobutrol chemical structure with rapid image acquisition. Particularly in (racemic). dynamic first-pass MRI studies, a tight bolus (i.e., a short-lasting bolus containing a high Thus, gadobutrol can provide diagnostic concentration of contrast agent) is a prerequi- information to classify benign and malignant site for good visualization [11]. A highly con- lesions independent of the body region under centrated contrast agent like gadobutrol is ideal examination. for such applications, resulting in high tran- sitory Gd concentrations in the area of inter- Overview of the market est, for example, in brain perfusion MRI and MRI is currently used for a wide range of clini- dynamic contrast-enhanced MR angiography cal applications and is not limited to specific (CE-MRA). body areas. In the majority of cases, extracel- lular contrast agents are used to improve the Introduction to the compound diagnostic inform ation in terms of lesion detec- Gadobutrol is an electrically neutral gadolin- tion, localization and differentiation between ium-containing contrast agent from a family benign and malignant lesions. Some more of macrocyclic compounds. Gadobutrol was targeted MR contrast agents exist that either designed to give radiologists an additional are blood-pool agents with a strong protein option of an MRI contrast agent with high binding affinity for MR angiography (MRA) relaxivity and a potential higher capacity to [8], or hepatocyte-specific agents like gadoxetate provide contrast in areas of interest. (Eovist® Bayer-Schering, Berlin, Germany, syn- onym Primovist®) or MultiHance® (Bracco Chemistry Diagnostics Inc., NJ, USA) for liver MRI [9]. The chemical name for Gadovist is In general, the clinical usefulness of extracel- [10-[2,3-dihydroxy-1-(hydroxymethyl) lular contrast agents for various applications propyl]-1,4,7,10-tetraazacyclododecane-1, 4,7-tri acetato- (3-)-N1,N4,N7,N10,O1,O4,O7] Table 1. Pharmacokinetic characteristics of gadobutrol. gadolinium (Figure 1). It has a molecular weight of 604.72 g/mole. It has a pK value of less than Pharmacokinetic characteristic 1.0 M gadobutrol mean (SD) 2.0 (conjugate acid) and a pH value of 6.0–8.0, Dose (mmol/kg bodyweight) 0.1 and it is freely soluble in water. Gadobutrol is AUC norm (µmol*h/l) 1074 (95.9) a nonionic injectable contrast medium for use t1/2p, b 1.78 (0.43) in MRI. It is provided as a sterile, clear, color- less and pyrogen-free aqueous, 0.5 or 1.0 mol/l Vss (l/kg) 0.21 (0.02) Cl (ml/mg/min) 1.56 (0.15) solution, which is ready for use. CLR (ml/mg/min) 1.56 (0.18) Pharmacodynamics Urine, 72 h Pl (% of dose) 100.3 (2.60) The signal intensity and contrast on MR Urine, 12 h Pl (% of dose) 98.0 (3.33) images is determined by the water content Feces, 72 h Pl (% of dose) 0.04 (0.02) and the behavior of the water protons in the Recovery (% of dose) 100.3 (2.60) magnetic field applied by the scanner, and AUC: Area under curve; Cl: Total clearance; CLR: Renal clearance; SD: Standard deviation; t1/2: Half‑life; Vss: Volume of distribution at steady state. the characteristic parameters for this are: the Data taken from [12]. (proton) relaxation times (T1 and T2); due to 26 Imaging Med. (2012) 4(1) future science group Overview on the efficacy & safety of gadobutrol CONTRAST AGENT EVALUATION Table 2. Number of patients by indication and dose in the Phase II–IV studies. Indication n CNS indications (cranial and spinal MRI, brain perfusion) 2448 Other ‘body’ areas 1139 Contrast-enhanced MR angiography 754 Myocardial perfusion 226 Pediatric patients 138 Total 4705 some inherent differences in these parameters abnormal vascularity (called first-pass imaging between normal tissue and pathological states as the contrast agent is still in the vessel within (e.g., lesions), water content is higher and relax- the first seconds after administration); leaking ation times are shorter, these differences allow through a disrupted blood barrier; or being dis- normal tissue and lesions to be differentiated. tributed into the extracellular space, thereby However, if the differences in these parameters increasing the contrast enhancement of a lesion are low or there is no difference, no delineation or displaying vessel structures. of organs, tissues and lesions is feasible. The use of the contrast agent causes enhance- Pharmacokinetics & metabolism ment of organs, tissues and lesions on MR Gadobutrol has first-order pharmacokinetics images by shortening the relaxation times T1 in the body.
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