Fluorescence Imaging of Disease Activity in IBD and Rheumatoid Arthritis Using OTL38
Status:
Not yet recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Rheumatoid Arthritis (RA) and inflammatory bowel disease (IBD) are both inflammatory diseases
caused by a persistent chronic inflammation. A chronic inflammation is caused by the absence
of the inflammation response resolution. Currently, diagnosis and disease activity
measurements are based on symptom-based scores or on anatomical imaging devices. Both methods
are unable to detect both early stages of the disease and early changes in inflammation as a
reaction to treatment. Objective, early measures of inflammation could improve diagnosis and
in the future therapeutic outcomes by identifying early therapy responders and
non-responders. The aim of this feasibility study is to evaluate the safety and feasibility
of the near infrared (NIR) tracer OTL38 for monitoring disease activity in inflammatory
diseases rheumatoid arthritis and inflammatory bowel disease. The hypothesis is that OTL38
will accumulate in inflamed tissue due to the increased presence of activated macrophages
expressing the folate beta receptor, enabling better visualization and monitoring of the
inflammation. It is expected that this approach can improve treatment and diagnosis of
patients with inflammatory disease.
Phase:
Phase 1
Details
Lead Sponsor:
University Medical Center Groningen
Collaborators:
GlaxoSmithKline On Target Laboratories, LLC VU University Medical Center