Investigating the safety, feasibility, and optimal dose of fluorescently labeled Adalimumab-680LT for visualizing drug targeting in Inflammatory Bowel Diseases.

Inflammatory Bowel Disease (IBD)

Monitoring of the vital signs before and after tracer administration and evaluating possible (severe) adverse events (SAE & AEs). Visual evaluation during FME (visible signal yes/no), TBR and CNR calculations, mean fluorescence intensities (MFIs) of biopsies, MDSFR/SFF measurements and fluorescence/ light sheet microscopy.

Comparison of in vivo fluorescence images, MFIs of biopsies, the MDSFR/SFF measurements, fluorescence microscopy results, and tracer concentrations inside biopsies before and after at least 14 weeks of adalimumab treatment., Quantification of MDSFR/SFF measurements in inflamed tissue compared to measurements in non-inflamed tissue. Positive correlation between MDSFR/SFF measurements and dose/inflammation severity?, Histologically ascertained tissue types (qualitative): • Normal (non-inflamed) ileal, colon and rectal tissue. • Inflamed ileum, colon and rectum tissue. • Random ‘’high-fluorescent’’ tissue • Random ‘’Non-fluorescent’’ tissue, Fluorescence (confocal) microscopy with additional use of immune panels and spatial transcriptomics analysis (before and after at least 14 weeks of adalimumab treatment). Measurements of the adalimumab-680LT concentration by light-sheet microscopy after tissue clearing, insights in adalimumab-target cells and presence of immune cells inside the biopsies and blood samples by flow cytometry and assessment of tracer stability by Western Blot.

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Netherlands