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

NCT06555042 | Recruiting

• 1 other identifier: VARHA/4573/13.02.02/2024
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease; Inflammatory Bowel Diseases; Crohn Disease of Small Intestine; Crohn Colitis; Crohn's Ileocolitis; Crohn Disease in Remission

Keywords

Inflammatory Bowel Disease; Positron emission tomography; Crohn's disease; Vascular adhesion protein-1; Intestinal Perfusion

Outcome Measures

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.

  18 months

Secondary Outcomes (2)

• VAP-1 immunohistochemistry

  18 months

• Tissue perfusion

  18 months

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead
• University of Turku: collaborator

Study Sites (1)

Turku PET Centre

Turku, Southwest Finland, 20540, Finland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue samples from endoscopy and whole blood.

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Jukka Koffert, M.D., Ph.D

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jukka Koffert, Ph.D.

CONTACT

+35823130000; jukka.koffert@varha.fi

Achol Bhowmik, B.M.

CONTACT

+358449832346; achol.a.bhowmik@utu.fi

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D., specialict in gastroenterology

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 15, 2024
• Study Start: September 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 6, 2026
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

FI (1)