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Title: First Human Experience with Directly Image-able Iodinated Embolization Microbeads

Abstract

PurposeTo describe first clinical experience with a directly image-able, inherently radio-opaque microspherical embolic agent for transarterial embolization of liver tumors.MethodologyLC 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).ResultsLC 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).ConclusionLC Bead LUMI™ image-able microbeads provide real-time feedback and geographic localization ofmore » 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.« less

Authors:
;  [1]; ; ;  [2];  [1];  [3];  [4];  [2];  [5]; ;  [1];  [6];  [1]
  1. National Institutes of Health, Center for Interventional Oncology (United States)
  2. Biocompatibles, UK Ltd, A BTG International Group Company (United Kingdom)
  3. Clinical Science IGT Systems North & Latin America, Philips, Philips, Image Guided Interventions (United States)
  4. Image-Guided Therapy Systems, Philips, Philips, Image Guided Interventions (Netherlands)
  5. Children’s National Medical Center (United States)
  6. Department of Radiology and Biomedical Imaging (United States)
Publication Date:
OSTI Identifier:
22645474
Resource Type:
Journal Article
Resource Relation:
Journal Name: Cardiovascular and Interventional Radiology; Journal Volume: 39; Journal Issue: 8; Other Information: Copyright (c) 2016 Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE); Article Copyright (c) 2016 Springer Science+Business Media New York (outside the USA) and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE); http://www.springer-ny.com; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; ARTERIES; COMPUTER CODES; COMPUTERIZED TOMOGRAPHY; EVALUATION; FLUOROSCOPY; HAZARDS; HEPATOMAS; HUMAN POPULATIONS; HYDROGELS; IMAGES; IODINE; LIVER; PATIENTS; PLANNING; POTENTIALS; PVA; VASCULAR DISEASES

Citation Formats

Levy, Elliot B., E-mail: levyeb@cc.nih.gov, Krishnasamy, Venkatesh P., Lewis, Andrew L., Willis, Sean, Macfarlane, Chelsea, Anderson, Victoria, Bom, Imramsjah MJ van der, Radaelli, Alessandro, Dreher, Matthew R., Sharma, Karun V., Negussie, Ayele, Mikhail, Andrew S., Geschwind, Jean-Francois H., and Wood, Bradford J.. First Human Experience with Directly Image-able Iodinated Embolization Microbeads. United States: N. p., 2016. Web. doi:10.1007/S00270-016-1364-8.
Levy, Elliot B., E-mail: levyeb@cc.nih.gov, Krishnasamy, Venkatesh P., Lewis, Andrew L., Willis, Sean, Macfarlane, Chelsea, Anderson, Victoria, Bom, Imramsjah MJ van der, Radaelli, Alessandro, Dreher, Matthew R., Sharma, Karun V., Negussie, Ayele, Mikhail, Andrew S., Geschwind, Jean-Francois H., & Wood, Bradford J.. First Human Experience with Directly Image-able Iodinated Embolization Microbeads. United States. doi:10.1007/S00270-016-1364-8.
Levy, Elliot B., E-mail: levyeb@cc.nih.gov, Krishnasamy, Venkatesh P., Lewis, Andrew L., Willis, Sean, Macfarlane, Chelsea, Anderson, Victoria, Bom, Imramsjah MJ van der, Radaelli, Alessandro, Dreher, Matthew R., Sharma, Karun V., Negussie, Ayele, Mikhail, Andrew S., Geschwind, Jean-Francois H., and Wood, Bradford J.. Mon . "First Human Experience with Directly Image-able Iodinated Embolization Microbeads". United States. doi:10.1007/S00270-016-1364-8.
@article{osti_22645474,
title = {First Human Experience with Directly Image-able Iodinated Embolization Microbeads},
author = {Levy, Elliot B., E-mail: levyeb@cc.nih.gov and Krishnasamy, Venkatesh P. and Lewis, Andrew L. and Willis, Sean and Macfarlane, Chelsea and Anderson, Victoria and Bom, Imramsjah MJ van der and Radaelli, Alessandro and Dreher, Matthew R. and Sharma, Karun V. and Negussie, Ayele and Mikhail, Andrew S. and Geschwind, Jean-Francois H. and Wood, Bradford J.},
abstractNote = {PurposeTo describe first clinical experience with a directly image-able, inherently radio-opaque microspherical embolic agent for transarterial embolization of liver tumors.MethodologyLC 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).ResultsLC 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).ConclusionLC 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.},
doi = {10.1007/S00270-016-1364-8},
journal = {Cardiovascular and Interventional Radiology},
number = 8,
volume = 39,
place = {United States},
year = {Mon Aug 15 00:00:00 EDT 2016},
month = {Mon Aug 15 00:00:00 EDT 2016}
}
  • The purpose of this study is to report on the feasibility, local response, and 1-year clinical outcome of bland transarterial embolization (TAE) with 40- and 100-{mu}m Embozene microspheres in patients affected by unresectable hepatocellular carcinoma (HCC). Up to January 2009, 53 patients underwent superselective TAE for a total of 74 lesions. Diagnosis of HCC was based on multidetector computed tomography (MDCT), {alpha}-fetoprotein, and biopsy. MDCT was performed 24 after treatment and repeated at 1 month, 3 months, and then every 6 months. Local efficacy was defined according to RECIST criteria. Technical success was always achieved. Local results at 1-month, 3-more » to 6-month, and 6- to 12-month follow-up were 62%, 37%, and 16%, respectively, for stable disease and 35%, 56%, and 51%, respectively, for partial response. Complete response (no evidence of lesion) has been observed only at late follow-up (three lesions; 7%). To date, 20 of 53 patients have had at least 1 year of follow-up, with an overall survival rate of 96%. Hepatic progressive disease (i.e., new nodules) was observed in 14 of 20 patients due to underlying liver disease. Minor complications were observed in four patients. A major complication occurred in one patient, who died unexpectedly 24 h after TAE due to pulmonary embolism of necrotic pathologic tissue and passage of particles through a disrupted hepatic vein. Local results as well as 1-year clinical outcome after TAE with Embozene microspheres are veryly encouraging, however, further studies, a larger patient population, and a longer follow-up are mandatory to assess the real clinical impact.« less
  • Radioiodinated estriol not previously derivatized was found to be immunoreactive and is shown to possess Sephadex-adsorptive characteristics similar to those of tritium-labeled estriol and nonlabeled estriol. Because of these characteristics, radioiodinated estriol is shown to be an acceptable radioligand for use in a rapid and reliable column radioimmunoassay for determination of unconjugated estriol in serum. An evaluation of the esteiol column RIA assay with this radioligand is presented.
  • Postmortem studies were made on 4 patients with liver metastases who had received radioactive iodatod human serum albumin intravenously shortly before death. No selective concentration of radioactive material by the liver or by the liver metastases could be demonstrated. (auth)
  • When /sup 125/I-iodinated human GH ((/sup 125/I)iodo-hGH) interacts with cultured human lymphocytes at 15 C, the reaction is reversible, but at 37 C the reaction becomes less dissociable as a function of incubation time. Acidification of the incubation medium results in rapid ligand dissociation at 15 C, but at 37 C the acid-dissociable component decreases as a function of incubation time. Under conditions where approximately 50% of the ligand is internalized by the cell, 90% is nondissociable. When the 37 C incubation is carried out in the presence of 25 mM NH/sub 4/Cl, cell-associated radioactivity is increased. Under these conditionsmore » approximately 90% of cell-associated radioactivity also is nondissociable. Using quantitative electron microscopic autoradiography, the proportion of (/sup 125/I)iodo-hGH associated with the plasma membrane and internalized by the cell is indistinguishable in the presence or absence of NH/sub 4/Cl. Irreversible (/sup 125/I)iodo-hGH association with cultured human lymphocytes is due to time- and temperature-dependent effects in the plasma membrane of the cell. These effects cannot be distinguished from internalization by acidification. Furthermore, lysosomotropic agents increase cell-associated radioactivity, but the proportion internalized is not increased.« less