Skip to content

Dual wavelength fluorescence imaging using fluorescently labelled adalimumab and risankizumab for visualizing drug targeting in Inflammatory Bowel Diseases (VOYAGER)

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521420-30-00
Acronym
21773
Enrollment
30
Registered
2026-01-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease (IBD)

Brief summary

Visual evaluation and distinction of both tracers during FME (visible signal yes/no), TBR and CNR calculations, mean fluorescence intensities (MFIs) of biopsies, MDSFR/SFF measurements and fluorescence/ light sheet microscopy

Detailed description

Analysis of in vivo fluorescence images and quantification of fluorescence signal in real-time by spectroscopy. Semi-quantification of the fluorescence within mucosal biopsies (FFPE) with fluorescence scans and comparison with endoscopic/histologic inflammation score and in vivo results. Look at possible correlation of in vivo and ex vivo measured and quantified fluorescence and endoscopic/histologic response to adalimumab/risankizumab therapy, Quantification of fluorescent signals by dual wavelengths spectroscopy during the endoscopy. Measurements will be correlated with fluorescence intensities visualized using the FME camera and endoscopic/histologic inflammation severity to draw any conclusions about adalimumab/risankizumab distribution into inflamed or non-inflamed tissue. We hypothesize a positive correlation between the fluorescence signal and the tracer dose and between the fluorescence signal and the inflammation scores, 3D ex vivo fluorescence signal analysis on intact biopsies taken in high and low fluorescence areas during the endoscopy to assess the distribution of labeled adalimumab-680LT/risankizumab-800CW. We use SDS-PAGE with protein extract of the biopsies obtained during the endoscopy procedures and the patients' blood samples to prove tracer integrity. We will detect the protein and mRNA expression of TNF and IL23 via Western Blot to determine a correlation between tracer signal and target expression, We will perform fluorescence microcopy on FFPE slides of the biopsies to microscopically visualize the adalimumab-680LT/risankizumab-800CW signal and perform additional immunofluorescence staining (CD68, CD3, CD8, CD20, etc.) for different immune cell types to identify the immune cell type of adalimumab-680LT/risankizumab-800CW positive cells

Interventions

Sponsors

Universitair Medisch Centrum Groningen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Visual evaluation and distinction of both tracers during FME (visible signal yes/no), TBR and CNR calculations, mean fluorescence intensities (MFIs) of biopsies, MDSFR/SFF measurements and fluorescence/ light sheet microscopy

Secondary

MeasureTime frame
Analysis of in vivo fluorescence images and quantification of fluorescence signal in real-time by spectroscopy. Semi-quantification of the fluorescence within mucosal biopsies (FFPE) with fluorescence scans and comparison with endoscopic/histologic inflammation score and in vivo results. Look at possible correlation of in vivo and ex vivo measured and quantified fluorescence and endoscopic/histologic response to adalimumab/risankizumab therapy, Quantification of fluorescent signals by dual wavelengths spectroscopy during the endoscopy. Measurements will be correlated with fluorescence intensities visualized using the FME camera and endoscopic/histologic inflammation severity to draw any conclusions about adalimumab/risankizumab distribution into inflamed or non-inflamed tissue. We hypothesize a positive correlation between the fluorescence signal and the tracer dose and between the fluorescence signal and the inflammation scores, 3D ex vivo fluorescence signal analysis on intact biopsi

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026