About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with a strong suspicion of small bowel's CD after the colonoscopy and laboratory studies will be recruited to study protocol in the outpatient gastroenterology clinic of Turku University Hospital.
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
VAP-1 expression in the small bowel of patients with Crohn's disease
VAP-1 is expressed in the small bowel of patients with Crohn's disease and can be assessed by \[68Ga\]Ga-DOTA-Siglec-9 PET/MRE.
Secondary outcomes
VAP-1 immunohistochemistry
VAP-1 is expressed in the small bowel of patients with Crohn's disease and can be assessed by immunohistochemical staining of tissue biopsies.
Tissue perfusion
Intestinal blood flow is increased in inflamed small bowel and decreased in the late fibrosing stages of Crohn's disease.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Turku University Hospital
Lead sponsor
University of Turku
Collaborator