NCT06555042 Investigation of VAP-1 Expression and Tissue Blood Flow by PET-MRI in Patients With Crohn's Disease
| NCT ID | NCT06555042 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Turku University Hospital |
| Condition | Crohn Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-09 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2024-09 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Jukka Koffert, M.D., Ph.D
PRINCIPAL INVESTIGATOR
Turku University Hospital
Frequently Asked Questions
Who can join the NCT06555042 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06555042 currently recruiting?
Yes, NCT06555042 is actively recruiting participants. Contact the research team at jukka.koffert@varha.fi for enrollment information.
Where is the NCT06555042 trial being conducted?
This trial is being conducted at Turku, Finland.
Who is sponsoring the NCT06555042 clinical trial?
NCT06555042 is sponsored by Turku University Hospital. The principal investigator is Jukka Koffert, M.D., Ph.D at Turku University Hospital. The trial plans to enroll 20 participants.