Combined [18F]-FDG PET-MRI in Diagnostics and Surveillance of Small Bowel Crohn's Disease

NCT06796959 | Completed

• 1 other identifier: ETMK 49/2019
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with suspected small bowel Crohn's disease (CD) are assessed with PET-MRE using 18-fluorodeoxyglucose (\[18F\]-FDG) tracer. Patients are recruited from the outpatient clinic of gastroenterology in Turku University Hospital. The patients must fulfil the eligibility criteria and give their signed approvement prior to their enrolment into the study. This is an observational single-center imaging study. 35 patients with high clinical suspicion of active small bowel CD will be enrolled to study. After the diagnostic \[18F\]-FDG-PET-MRE, patients will undergo small bowel capsule endoscopy (SBCE) if no strictures are seen in PET-MRE. \[18F\]-FDG-PET-MRE will be repeated in 3 months after medical therapy for CD has been started. Medical therapy will be started by clinicians blinded from PET-data but have access to MRE-data and all other diagnostic measures. Adequate medication is chosen by clinicians not participating in the study and thus enrollment does not affect the choice of medical therapy for patients participating in this study. \[18F\]-FDG-PET-MRE and clinical assessment of disease activity will be performed within 1 month of recruitment. Follow up-visits will be arranged in the outpatient clinic of gastroenterology in Turku University Hospital. The aim is to investigate whether \[18F\]-FDG-PET-MRE can be used in diagnostics and follow-up of small bowel CD and to compare its performance to MRE.

Conditions

Small Bowel Crohn's Disease

Keywords

small bowel Crohn's disease; ileitis

Outcome Measures

Primary Outcomes (1)

• Standard uptake value in diagnostics of small bowel CD

  Primary outcome is to show that standard uptake values (SUV) measured in \[18F\]-FDG-PET-MRE are higher in patients with CD than in patients not diagnosed with CD.

  Immediate

Secondary Outcomes (1)

• Change in standardized uptake values (SUV) in follow-up

  Six months

Study Arms (1)

Study subjects

Patients with suspected small bowel Crohn's disease

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 are enrolled from outpatient clinic of gastroenterology of Turku University Hospital

You may qualify if:

• clinically suspected small bowel CD
• or ileitis in colonoscopy
• or diarrhea or anemia and elevated fecal calprotectin
• or suspected CD in cross sectional imaging)

You may not qualify if:

• age under 18 or above 70
• pregnancy
• metformin-medication
• claustrophobia
• previously known small bowel CD

Sponsors & Collaborators

• Turku University Hospital: lead
• Finnish governmental support for health sciences: collaborator
• Mary and Georg Ehrnroot's foundation: collaborator

Study Sites (1)

Turku PET Center

Turku, 20521, Finland

Location

Related Publications (2)

• Mattila J, Kallio J, Loyttyniemi E, Nuutila P, Koffert J. Combined [18F]-Fluorodeoxyglucose Positron Emission Tomography-MR Imaging: A Promising Tool for Diagnostics of Small Bowel Crohn's Disease. Dig Dis. 2025;43(1):104-114. doi: 10.1159/000542379. Epub 2024 Nov 13.

  PMID: 39536721 BACKGROUND

• Mattila J, Kallio J, Loyttyniemi E, Nuutila P, Koffert J. Combined [18F]-FDG PET-MR imaging for monitoring small bowel crohn's disease. Eur J Nucl Med Mol Imaging. 2026 Jan;53(2):1234-1245. doi: 10.1007/s00259-025-07524-4. Epub 2025 Aug 26.

  PMID: 40856818 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue samples from small bowel Venous blood samples

MeSH Terms

Conditions

Ileitis

Condition Hierarchy (Ancestors)

Enteritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Ileal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 28, 2025
• Study Start: August 1, 2020
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 1.8.2020-1.8.2030
• Access Criteria: Anonymized research data sets will be preserved and made accessible through the Finnish Social Science Data Archives once the whole project is finalized.

Locations

FI (1)