Evidence map›Paper›PMID 27206503›Full record

ArticleCardiovascular and interventional radiology2016

First Human Experience with Directly Image-able Iodinated Embolization Microbeads.

Elliot B Levy, Venkatesh P Krishnasamy, Andrew L Lewis, Sean Willis, Chelsea Macfarlane, Victoria Anderson, Imramsjah Mj van der Bom, Alessandro Radaelli, Matthew R Dreher, Karun V Sharma and 4 more

Registry-linked trialAbstract readCase Reports
In one paragraph

Article in Cardiovascular and interventional radiology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03452553 (A Prospective, US Multicenter Open Label Study in the Treatment of Hepatocellular Carcinoma), which is not on this map. Cited by 31 papers.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03452553 nawithdrawnnot on this mapstarted 2018, after this paper: background citation

A Prospective, US Multicenter Open Label Study in the Treatment of Hepatocellular Carcinoma (HCC) With a Radiopaque (RO) Bead (LC Bead LUMI™) Loaded With Doxorubicin

TypeinterventionalSponsorBoston Scientific CorporationRan2018 to 2020Enrolled0ConditionsHepatocellular Carcinoma (HCC)ArmsLC Bead LUMI™ (Radiopaque (RO) Bead) loaded with doxorubicin
3 · Its place in the literature

Who cites it

31 citing papers in PubMed.

  1. Article
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  14. Handling and performance characteristics of a new small caliber radiopaque embolic microsphere.Journal of biomedical materials research. Part B, Applied biomaterials · 2020
    Article
  15. Emerging Embolic Agents in Endovascular Embolization: An Overview.Progress in biomedical engineering (Bristol, England) · 2020
    Article
  16. Article
  17. Article
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Elliot B LevyCenter for Interventional Oncology, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD, USA. levyeb@cc.nih.gov.
Venkatesh P KrishnasamyCenter for Interventional Oncology, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD, USA.
Andrew L LewisBiocompatibles, UK Ltd, A BTG International Group Company, Lakeview, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, UK.
Sean WillisBiocompatibles, UK Ltd, A BTG International Group Company, Lakeview, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, UK.
Chelsea MacfarlaneBiocompatibles, UK Ltd, A BTG International Group Company, Lakeview, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, UK.
Victoria AndersonCenter for Interventional Oncology, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD, USA.
Imramsjah Mj van der BomPhilips, Image Guided Interventions, Clinical Science IGT Systems North & Latin America, Philips, 2 Canal Park, Cambridge, MA, 02141, USA.
Alessandro RadaelliPhilips, Image Guided Interventions, Image-Guided Therapy Systems, Philips, Veenpluis 4-6, 5680 DA, Best, The Netherlands.
Matthew R DreherBiocompatibles, UK Ltd, A BTG International Group Company, Lakeview, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, UK.
Karun V SharmaChildren's National Medical Center, 111 Michigan Ave NW, Washington, DC, 20010, USA.
Ayele NegussieCenter for Interventional Oncology, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD, USA.
Andrew S MikhailCenter for Interventional Oncology, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD, USA.
Jean-Francois H GeschwindDepartment of Radiology and Biomedical Imaging, 330 Cedar Street, PO Box 208042, New Haven, CT, 06520, USA.
Bradford J WoodCenter for Interventional Oncology, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD, USA.

Funding

Center for Interventional OncologyZIDBC011242 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI WOOD, BRADFORD J · 2009 to 2025
$18.7M
Navigation Tools for Image Guided Minimally invasive TherapiesZIACL040011 · CLC · CLINICAL CENTER · PI WOOD, BRADFORD · 2009 to 2025
$0k
Interventional OncologyZIACL040015 · CLC · CLINICAL CENTER · PI WOOD, BRADFORD · 2009 to 2025
$0k
Intramural NIH HHS ZID BC011242
6 · The paper itself

Abstract

purposeTo describe first clinical experience with a directly image-able, inherently radio-opaque microspherical embolic agent for transarterial embolization of liver tumors. METHODOLOGY: 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).

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.

Indexed as

Acrylic ResinsAged, 80 and overAngiography, Digital SubtractionCarcinoma, HepatocellularCone-Beam Computed TomographyEmbolization, TherapeuticFluoroscopyHumansLiverLiver NeoplasmsMaleMicrospheresMiddle AgedPolyvinyl AlcoholTreatment OutcomeAcrylic ResinsPolyvinyl Alcoholpolyvinyl alcohol hydrogelRadio-Opaque acrylic resinEmbolizationHepaticImage-able

Identifiers

PMID27206503
PMCPMC7831151

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.