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

NCT06796959 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2025-02-05

No results posted yet for this study

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

Sponsors & Collaborators

  • Finnish governmental support for health sciences

    collaborator UNKNOWN

  • Mary and Georg Ehrnroot's foundation

    collaborator UNKNOWN

  • Turku University Hospital

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06796959 on ClinicalTrials.gov