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NCT06796959: CD-PET

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

Completed Last updated 5 February 2025
What this trial tests

trial in Small Bowel Crohn's Disease in 35 participants. Completed in 31 October 2024.

Timeline
1 August 2020
Primary endpoint
31 October 2024
31 October 2024

Quick facts

Lead sponsorTurku University Hospital
StatusCompleted
Study typeOBSERVATIONAL
Enrollment35
Start date1 August 2020
Primary completion31 October 2024
Estimated completion31 October 2024
Sites1 location across Finland

Conditions studied

Sponsor

Turku University Hospital

Who can join

Adults 18 to 70, any sex, with Small Bowel Crohn's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Combined [<sup>18</sup>F]-FDG PET-MR imaging for monitoring small bowel crohn's disease.
    Mattila J, Kallio J, Löyttyniemi E, Nuutila P, et al · · 2026 · PMID 40856818 · DOI 10.1007/s00259-025-07524-4

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