Long-term biocompatibility, imaging appearance and tissue effects associated with delivery of a novel radiopaque embolization bead for image-guided therapy

Abstract

The objective of this study was to undertake a comprehensive long-term biocompatibility and imaging assessment of a new intrinsically radiopaque bead (LC Bead LUMI™) for use in transarterial embolization. The sterilized device and its extracts were subjected to the raft of ISO10993 biocompatibility tests that demonstrated safety with respect to cytotoxicity, mutagenicity, blood contact, irritation, sensitization, systemic toxicity and tissue reaction. Intra-arterial administration was performed in a swine model of hepatic arterial embolization in which 0.22-1 mL of sedimented bead volume was administered to the targeted lobe(s) of the liver. The beads could be visualized during the embolization procedure with fluoroscopy, DSA and single X-ray snapshot imaging modalities. CT imaging was performed before and 1 h after embolization and then again at 7, 14, 30 and 90 days. LC Bead LUMI™ could be clearly visualized in the hepatic arteries with or without administration of IV contrast and appeared more dense than soluble contrast agent. The CT density of the beads did not deteriorate during the 90 day evaluation period. The beads embolized predictably and effectively, resulting in areas devoid of contrast enhancement on CT imaging suggesting ischaemia-induced necrosis nearby the sites of occlusion. Instances of off target embolization were easily detected on imaging and confirmed pathologically. Histopathology revealed a classic foreign body response at 14 days, which resolved over time leading to fibrosis and eventual integration of the beads into the tissue, demonstrating excellent long-term tissue compatibility.

Vandetanib-eluting Radiopaque Beads: In vivo Pharmacokinetics, Safety and Toxicity Evaluation following Swine Liver Embolization

“…There was no obvious difference in the radiopacity between VERB with different drug doses used in the phase one study, despite the drug potentially contributing slightly to the overall radiopacity due to the presence of radiodense bromine atoms on the drug structure 34. The radiopacity of the beads did not change over the 90 day period confirming the stability of the device as demonstrated previously with this radiopaque platform 37.…”

“…This evaluation was performed in a swine liver embolization safety model 36, 37 at MPI Research Inc. (Mattawan, Michigan, USA) using male experimentally naïve domestic Yorkshire crossbred swine (farm pigs, weights 53.5 - 66.5 kg at randomization). The study conformed to USDA Animal Welfare Act (9 CFR parts 1, 2 and 3) and the 'Guide for the Care and Use of Laboratory Animals', Institute of Laboratory Animal Resources, National Academy Press, Washington, D.C, 2011.…”

Sorafenib and 2,3,5-triiodobenzoic acid-loaded imageable microspheres for transarterial embolization of a liver tumor

“…Considering its hydrophobic and degradable characteristics, it can be used for the fabrication of MSs and the sustained release of poorly water soluble drugs; as a result, biosafety can be accomplished 24 . It seems that TIBA may be one of the appropriate iodine derivatives for preparing particles with suitable physicochemical properties ( i.e ., dispersibility and sphericity), radiopacity, and biocompatibility 25–27 . Following fabrication, the particle size, biodegradability, drug release profiles, and CT imaging properties of MSs were characterized in vitro .…”

Application of PLGA-ion exchange resin microcapsules of sulfasalazine ‎for embolization therapy

“…Two rabbits were used to evaluate the embolization property for selected microcapsules formula (F19), the rabbits ears had been prepared for injection by wiping with sterile tissue then (24G) cannula had been inserted in ear central artery through which 3 ml suspension containing (30 mg) of sterile microcap sules (F19) was injected slowly. 22,23 Results and Discussion…”