Investigation of VAP-1 Expression and Tissue Blood Flow by PET-MRI in Patients With Crohn's Disease
Recruiting · NCT06555042 · Observational (researchers observe without assigning treatment) · Lead sponsor: Turku University Hospital
View the official record on ClinicalTrials.gov →What this trial is about
This is an observational, single center, imaging study. The CD patients with active disease will be assessed by \[68Ga\]Ga-DOTA-Siglec-9 and \[15O\]H2O PET/MRE. Patients with high clinical suspicion of small intestine's CD in outpatient gastroenterology clinic of Turku University Hospital will be recruited. The patients must fulfil the eligibility criteria and give their signed approvement prior to their enrolment into the study. 20 patients with high suspicion of active small bowels CD will be enrolled to being evaluated for potential participation in this study. In patients with diagnosed small bowels CD, PET-MRE will be repeated 3 months after the initial imaging (and based on clinical diagnostic started medication) to verify disease remission/inadequacy of the treatment. Assessments for CD clinical disease activity will be performed at screening and \[68Ga\]Ga-DOTA-Siglec-9 and \[15O\]H2O PET/MRE assessments will be performed within a month for each patient. After PET/MRE all patients can be treated according to patients' needs with immunosuppressive drugs. Follow-up visits are organized at after PET/MRE imaging at gastroenterology outpatient clinic.
Who can take part
Inclusion criteria
- Adults between age 18-70
- Strong clinical suspicion of small bowel Crohn's disease
- Able and willing to give written informed consent and to comply with the study protocol
Exclusion criteria
- Pregnant or breast-feeding women
- Previous capsule retention
- X-ray investigations during preceding year
- Patients with metallic implants such as an electronic pacemaker or an implanted infusion pump
- Known stenosis of the GI-tract
- Evidence of significant uncontrolled concomitant diseases such as neurological, renal, hepatic, endocrine, or gastrointestinal disorders which, in the opinion of the Investigator, would preclude patient participation
- Is unable or unwilling to comply with the study protocol for any reason
Where it is running
1 location listed.
- Turku PET Centre - Turku, Southwest Finland, Finland