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NCT06796959Completed

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

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

Source: ClinicalTrials.gov · Last updated 5 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
35 (actual)
First submitted
21 Jan 2025
Start date
1 Aug 2020
Primary completion date
31 Oct 2024
Lead sponsor
Turku University Hospital
NCT number
NCT06796959

What you commit to

  • Study type: Observational
  • Participants enrolled: 35
  • From 1 Aug 2020 to the primary completion date, 31 Oct 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • metformin-medication
  • previously known small bowel CD

Age

  • age under 18 or above 70

Other

  • pregnancy
  • claustrophobia

Who the study is looking for

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

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Turku PET Center
Coordinator of this site? Confirm its status
TurkuFinlandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.