Investigation of VAP-1 Expression and Tissue Blood Flow by PET-MRI in Patients With Crohn's Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorTurku University Hospital

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
18 months

Secondary outcomes

1

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.

Time frame
18 months
2

Tissue perfusion

Intestinal blood flow is increased in inflamed small bowel and decreased in the late fibrosing stages of Crohn's disease.

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Turku University Hospital

Lead sponsor

University of Turku

Collaborator