title: First Human Experience with Directly Image-able Iodinated Embolization Microbeads.
abstract: OBJECTIVE
  To describe first clinical experience with a directly image-able, inherently radio-opaque microspherical embolic agent for transarterial embolization of liver tumors.
  
  
  METHODS
  LC Bead LUMI™ is a new product based upon sulfonate-modified polyvinyl alcohol hydrogel microbeads with covalently bound iodine (~260 mg I/ml). 70-150 μ LC Bead LUMI™ iodinated microbeads were injected selectively via a 2.8 Fr microcatheter to near complete flow stasis into hepatic arteries in three patients with hepatocellular carcinoma, carcinoid, or neuroendocrine tumor. A custom imaging platform tuned for LC LUMI™ microbead conspicuity using a cone beam CT (CBCT)/angiographic C-arm system (Allura Clarity FD20, Philips) was used along with CBCT embolization treatment planning software (EmboGuide, Philips).
  
  
  RESULTS
  LC Bead LUMI™ image-able microbeads were easily delivered and monitored during the procedure using fluoroscopy, single-shot radiography (SSD), digital subtraction angiography (DSA), dual-phase enhanced and unenhanced CBCT, and unenhanced conventional CT obtained 48 h after the procedure. Intra-procedural imaging demonstrated tumor at risk for potential under-treatment, defined as paucity of image-able microbeads within a portion of the tumor which was confirmed at 48 h CT imaging. Fusion of pre- and post-embolization CBCT identified vessels without beads that corresponded to enhancing tumor tissue in the same location on follow-up imaging (48 h post).
  
  
  CONCLUSIONS
  LC Bead LUMI™ image-able microbeads provide real-time feedback and geographic localization of treatment in real time during treatment. The distribution and density of image-able beads within a tumor need further evaluation as an additional endpoint for embolization.
authors.affiliation: Center for Interventional Oncology, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD, USA. levyeb@cc.nih.gov.
authors.forename: Elliot B
authors.initials: EB
authors.lastname: Levy
authors.affiliation: Center for Interventional Oncology, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD, USA.
authors.forename: Venkatesh P
authors.initials: VP
authors.lastname: Krishnasamy
authors.affiliation: Biocompatibles, UK Ltd, A BTG International Group Company, Lakeview, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, UK.
authors.forename: Andrew L
authors.initials: AL
authors.lastname: Lewis
authors.affiliation: Biocompatibles, UK Ltd, A BTG International Group Company, Lakeview, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, UK.
authors.forename: Sean
authors.initials: S
authors.lastname: Willis
authors.affiliation: Biocompatibles, UK Ltd, A BTG International Group Company, Lakeview, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, UK.
authors.forename: Chelsea
authors.initials: C
authors.lastname: Macfarlane
authors.affiliation: Center for Interventional Oncology, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD, USA.
authors.forename: Victoria
authors.initials: V
authors.lastname: Anderson
authors.affiliation: Philips, Image Guided Interventions, Clinical Science IGT Systems North & Latin America, Philips, 2 Canal Park, Cambridge, MA, 02141, USA.
authors.forename: Imramsjah Mj
authors.initials: IM
authors.lastname: van der Bom
authors.affiliation: Philips, Image Guided Interventions, Image-Guided Therapy Systems, Philips, Veenpluis 4-6, 5680 DA, Best, The Netherlands.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Radaelli
authors.affiliation: Biocompatibles, UK Ltd, A BTG International Group Company, Lakeview, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, UK.
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Dreher
authors.affiliation: Children's National Medical Center, 111 Michigan Ave NW, Washington, DC, 20010, USA.
authors.forename: Karun V
authors.initials: KV
authors.lastname: Sharma
authors.affiliation: Center for Interventional Oncology, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD, USA.
authors.forename: Ayele
authors.initials: A
authors.lastname: Negussie
authors.affiliation: Center for Interventional Oncology, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD, USA.
authors.forename: Andrew S
authors.initials: AS
authors.lastname: Mikhail
authors.affiliation: Department of Radiology and Biomedical Imaging, 330 Cedar Street, PO Box 208042, New Haven, CT, 06520, USA.
authors.forename: Jean-Francois H
authors.initials: JF
authors.lastname: Geschwind
authors.affiliation: Center for Interventional Oncology, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD, USA.
authors.forename: Bradford J
authors.initials: BJ
authors.lastname: Wood
mesh_terms: D000180:Acrylic Resins / Q000627:therapeutic use; D000369:Aged, 80 and over; D015901:Angiography, Digital Subtraction; D006528:Carcinoma, Hepatocellular / Q000000981:diagnostic imaging / Q000628:therapy*; D054893:Cone-Beam Computed Tomography / Q000379:methods; D004621:Embolization, Therapeutic / Q000379:methods*; D005471:Fluoroscopy; D006801:Humans; D008099:Liver / Q000000981:diagnostic imaging; D008113:Liver Neoplasms / Q000000981:diagnostic imaging / Q000628:therapy*; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D011142:Polyvinyl Alcohol / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000180:Acrylic Resins; C062364:polyvinyl alcohol hydrogel; D011142:Polyvinyl Alcohol; C041289:Radio-Opaque acrylic resin
keywords: Embolization; Hepatic; Image-able