Evidence map›Paper›PMID 39412619›Full record

ArticleEJNMMI physics2024

Development and validation of an innovative administration system to facilitate controlled holmium-166 microsphere administration during TARE.

Meike W M van Wijk, Gerhard van Wolfswinkel, Mark J Arntz, Marcel J R Janssen, Joey Roosen, J Frank W Nijsen

Registry-linked trialAbstract read
In one paragraph

Article in EJNMMI physics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05183776 (Clinical Validation of a Fractional Administration Device for Holmium-166 Microspheres During Selective Internal Radiation Therapy in Patients With Liver Tumours), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT05183776 nacompletednot on this map

Clinical Validation of a Fractional Administration Device for Holmium-166 Microspheres During Selective Internal Radiation Therapy in Patients With Liver Tumours

TypeinterventionalSponsorRadboud University Medical CenterRan2022 to 2023Enrolled5ConditionsLiver Cancer, Liver Metastasis Colon Cancer, Primary Liver CancerArmsFractional administration device
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. In Vitro Investigation of Microcatheter Behavior During Microsphere Injection in Transarterial Radioembolization.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2026
    Article
  2. Article
  3. Article
  4. Hepatobiliary PET with [EJNMMI research · 2025
    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

6 authors.

Meike W M van WijkDepartment of Medical Imaging, Radboud University Medical Center, Nijmegen, The Netherlands. Meike.vanwijk@radboudumc.nl.ORCID http://orcid.org/0000-0002-4626-6694
Gerhard van WolfswinkelR&D TIO, Quirem Medical B.V. - A Terumo Company, Deventer, The Netherlands.
Mark J ArntzDepartment of Medical Imaging, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID http://orcid.org/0000-0002-2402-7617
Marcel J R JanssenDepartment of Medical Imaging, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID http://orcid.org/0000-0002-2567-7734
Joey RoosenDepartment of Medical Imaging, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID http://orcid.org/0000-0002-7965-6664
J Frank W NijsenDepartment of Medical Imaging, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID http://orcid.org/0000-0001-7625-2253

Funding

Terumo Terumo
6 · The paper itself

Abstract

backgroundTo develop and validate a novel administration device for holmium-166 transarterial radioembolisation (TARE) with the purpose of facilitating controlled fractional microsphere administration for a more flexible and image-guided TARE procedure.

methodsA Controlled Administration Device (CAD) was developed using MR-conditional materials. The CAD contains a rotating syringe to keep the microspheres in suspension during administration. Different rotational speeds were tested ex vivo to optimise the homogeneity of microsphere fractions administered from the device. The technical performance, accuracy, and safety was validated in three patients in a clinical TARE setting by administering a standard clinical dose in 5 fractions (identifier: NCT05183776). MRI-based dosimetry was used to validate the homogeneity of the given fractions in vivo, and serious adverse device event ((S)A(D)E) reporting was performed to assess safety of the CAD.

resultsA rotational speed of 30 rpm resulted in the most homogeneous microsphere fractions with a relative mean deviation of 1.1% (range: -9.1-8.0%). The first and last fraction showed the largest deviation with a mean of -26% (std. 16%) and 7% (std. 13%). respectively. In the three patient cases the homogeneity of the microsphere fractions was confirmed given that MRI-based dosimetry showed near linear increase of mean absorbed target liver dose over the given fractions with R

conclusionsThe newly developed CAD facilitates safe and accurate fractional microsphere administration during TARE, and can be used for multiple applications in the current and future workflows of TARE.

Indexed as

HolmiumImage-guidedLiverPersonalisationSIRTTARETreatment delivery

Identifiers

PMID39412619
PMCPMC11484995

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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.