Evidence map›Paper›PMID 38580386›Full record

ArticleGut2024

Fluorescently labelled vedolizumab to visualise drug distribution and mucosal target cells in inflammatory bowel disease.

Ruben Y Gabriëls, Anne M van der Waaij, Matthijs D Linssen, Michael Dobosz, Pia Volkmer, Sumreen Jalal, Dominic Robinson, Marcela A Hermoso, Marjolijn N Lub-de Hooge, Eleonora A M Festen and 3 more

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in Gut, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04112212 (Using Fluorescently Labeled Vedolizumab to Visualize Local Drug Distribution During Colonoscopy and Identify Mucosal Target Cells in Patients With Inflammatory Bowel Disease), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing 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.

NCT04112212 phase1completednot on this map

Using Fluorescently Labeled Vedolizumab to Visualize Local Drug Distribution During Colonoscopy and Identify Mucosal Target Cells in Patients With Inflammatory Bowel Disease

TypeinterventionalSponsorUniversity Medical Center GroningenRan2020 to 2023Enrolled38ConditionsCrohn Disease, Colitis, UlcerativeArmsFluorescence molecular imaging procedure using vedolizumab-800CW, Fluorescence molecular imaging procedure without prior administration of vedolizumab-800CW, Fluorescence molecular imaging procedure using vedolizumab-800CW with prior administration of unlabeled vedolizumab
3 · Its place in the literature

Who cites it

15 citing papers in PubMed.

  1. Targeted Fluorescence Imaging of Bevacizumab-800CW in Patients with Neovascular Age-Related Macular Degeneration.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026
    Trial
  2. Article
  3. More Than a Glow: How Cyanine Dyes Shape Tracer Pharmacokinetics.Angewandte Chemie (International ed. in English) · 2026
    Review
  4. Article
  5. Review
  6. Review
  7. Article
  8. New Technologies for IBD Endoscopy.Journal of clinical medicine · 2026
    Review
  9. Review
  10. Article
  11. Article
  12. Gut-directed therapeutics in inflammatory bowel disease.Current opinion in gastroenterology · 2025
    Review
  13. Review
  14. Review
  15. Review
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

13 authors.

Ruben Y Gabriëls *Department of Gastroenterology and Hepatology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.ORCID 0000-0001-5435-2165
Anne M van der Waaij *Department of Gastroenterology and Hepatology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.
Matthijs D Linssen *Department of Gastroenterology and Hepatology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.
Michael Dobosz *Department of Oncology and Immuno-Oncology, Regeneron Pharmaceuticals inc, Tarrytown, New York, USA.
Pia VolkmerDepartment of Gastroenterology and Hepatology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.
Sumreen JalalDepartment of Oncology and Immuno-Oncology, Regeneron Pharmaceuticals inc, Tarrytown, New York, USA.
Dominic RobinsonCentre for Optical Diagnostics and Therapy, Department of Otorhinolaryngology and Head and Neck Surgery, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
Marcela A HermosoDepartment of Gastroenterology and Hepatology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.
Marjolijn N Lub-de HoogeDepartment of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.
Eleonora A M FestenDepartment of Gastroenterology and Hepatology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.
Gursah Kats-UgurluDepartment of Pathology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.
Gerard DijkstraDepartment of Gastroenterology and Hepatology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.ORCID 0000-0003-4563-7462
Wouter B NagengastDepartment of Gastroenterology and Hepatology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands w.b.nagengast@umcg.nl.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveImproving patient selection and development of biological therapies such as vedolizumab in IBD requires a thorough understanding of the mechanism of action and target binding, thereby providing individualised treatment strategies. We aimed to visualise the macroscopic and microscopic distribution of intravenous injected fluorescently labelled vedolizumab, vedo-800CW, and identify its target cells using fluorescence molecular imaging (FMI).

designForty three FMI procedures were performed, which consisted of macroscopic in vivo assessment during endoscopy, followed by macroscopic and microscopic ex vivo imaging. In phase A, patients received an intravenous dose of 4.5 mg, 15 mg vedo-800CW or no tracer prior to endoscopy. In phase B, patients received 15 mg vedo-800CW preceded by an unlabelled (sub)therapeutic dose of vedolizumab.

resultsFMI quantification showed a dose-dependent increase in vedo-800CW fluorescence intensity in inflamed tissues, with 15 mg (153.7 au (132.3-163.7)) as the most suitable tracer dose compared with 4.5 mg (55.3 au (33.6-78.2)) (p=0.0002). Moreover, the fluorescence signal decreased by 61% when vedo-800CW was administered after a therapeutic dose of unlabelled vedolizumab, suggesting target saturation in the inflamed tissue. Fluorescence microscopy and immunostaining showed that vedolizumab penetrated the inflamed mucosa and was associated with several immune cell types, most prominently with plasma cells.

conclusionThese results indicate the potential of FMI to determine the local distribution of drugs in the inflamed target tissue and identify drug target cells, providing new insights into targeted agents for their use in IBD. TRIAL REGISTRATION NUMBER: NCT04112212.

Indexed as

Antibodies, Monoclonal, HumanizedGastrointestinal AgentsInflammatory Bowel DiseasesIntestinal MucosaAdultAgedDose-Response Relationship, DrugFemaleFluorescent DyesHumansMaleMiddle AgedMolecular ImagingYoung AdultAntibodies, Monoclonal, HumanizedFluorescent DyesGastrointestinal AgentsvedolizumabANTIBODY TARGETED THERAPYFLUORESCENCE ENDOSCOPYIBDPHARMACOKINETICS

Identifiers

PMID38580386
PMCPMC11347245

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.