%0 Journal Article
%T Immunological evaluation of the new stable ultrasound contrast agent LK565: a phase one clinical trial
%A B Funke
%A HK Maerz
%A S Okorokow
%A S Polata
%A I Lehmann
%A U Sack
%A P Wild
%A T Geisler
%A RJ Zotz
%J Cardiovascular Ultrasound
%D 2004
%I BioMed Central
%R 10.1186/1476-7120-2-16
%X A phase one clinical study was conducted on 15 healthy volunteers to identify the development of an undesirable immune response. Phagocytosis capacity, TNF-¦Á secretion, and MHC class II upregulation of monocytes was monitored, as well as microsphere specific antibody development (IgM, IgG). Furthermore, the kinetics of the activation surface markers CD69, CD25, CD71, and CD11b on leukocytes were analyzed.Due to LK565-metabolism the administration of the UCA led to saturation of phagocytes which was reversible after 24 hrs. Compared to positive controls neither significant TNF-¦Á elevation, neither MHC class II and activation surface markers upregulation, nor specific antibody development was detectable.The administration of LK565 provides a comfortable duration of signal enhancement, esp. in echocardiography, without causing a major activation cascade or triggering an adaptive immune response. To minimize the risk of undesirable adverse events such as anaphylactoid reactions, immunological studies should be included in clinical trials for new UCAs. The use of LK565 as another new ultrasound contrast agent should be encouraged as a safe means to provide additional diagnostic information.Echocardiography allows the analysis of ventricular motion and heart-valve morphology. The discovery that injection of small air bubbles dispensed in saline are capable of causing an opacification of the heart [1,2] started an enormous effort to develop contrast agents to assist in diagnosing coronary artery disease and myocardial infarction [3]. Early developments led to stabilized bubbles in hyperosmolar solutions [4]. Albumin-stabilized bubbles were one of the first contrast agents to allow examination of both ventricles [5], but there are stability problems in patients with elevated pulmonary pressure [6]. Second-generation contrast agents improved the contrast especially in patients with subnormal echo signals [7-9]. LK565 and comparable substances represent a new concept in contr
%U http://www.cardiovascularultrasound.com/content/2/1/16