RecruitingNCT06555042

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

Investigation of VAP-1 Expression and Tissue Blood Flow by Combined [68Ga]DOTA-Siglec-9 and [15O]H2O PET-MRI in Patients With Small Bowel's Crohn's Disease


Sponsor

Turku University Hospital

Enrollment

20 participants

Start Date

Sep 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is using a specialized imaging technique (PET-MRI with a tracer targeting VAP-1, a protein involved in inflammation) to examine blood flow and inflammation in the small intestine of patients suspected of having Crohn's disease — a chronic inflammatory condition of the digestive tract. The goal is to see if this imaging approach can better detect and characterize bowel inflammation. **You may be eligible if...** - You are 18–70 years old - You have a strong clinical suspicion of small bowel Crohn's disease that your doctor is evaluating - You are willing and able to follow the study protocol and give written consent **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have previously had a capsule retained in the digestive tract - You have had X-ray investigations in the past year - You have a pacemaker, infusion pump, or other metallic implant incompatible with MRI - You have a known narrowing (stenosis) of the digestive tract - You have significant uncontrolled health conditions that the investigator feels would put you at risk Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Turku PET Centre

Turku, Southwest Finland, Finland

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NCT06555042


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