Combined PET-MRI in the Diagnostics of Chronic Inflammatory Bowel Diseases (IBD)- a Feasibility Study

Study Overview
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Brief Summary
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The main purpose of the present study is to examine the diagnostic performance of combined PET-MRI in detecting colonic and small bowel wall inflammatory processes caused by ulcerative colitis and Crohn's disease.

Detailed Description
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COMBINED PET-MRI IN THE DIAGNOSTICS OF CHRONIC INFLAMMATORY BOWEL DISEASES (IBD)- A FEASIBILITY STUDY (RESEARCH CODE T31/2014) Background Ulcerative colitis and Crohn's disease are chronic inflammatory bowel diseases (IBD) with relapsing and remitting course. The incidence of IBD is highest in teenagers and young adults, but IBD may also affect children and old people. The diagnosis of IBD is based on clinical symptoms, endoscopy and histology of the bowel wall. Aims of the study The main purpose of the present study is to examine the diagnostic performance of combined PET-MRI in detecting colonic and small bowel wall inflammatory processes caused by ulcerative colitis and Crohn's disease. The hypothesis of the study is a) IBD-related inflammatory changes are detected by PET-MRI (18 F-FDG) and correlate with the endoscopic and histologic activity of colitis and ileitis. Study design A total of 45 IBD patients (ulcerative colitis or Crohn's disease) aged over 15 years will be recruited from the patients visiting outpatient gastroenterology clinic of Turku University Hospital. Every patient undergoes colonoscopy with biopsy specimens, endoscopic and histologic data are recorded via structured forms. Laboratory specimens with samples for biobank are obtained. Then the patients are examined by abdominal MRI and PET. Inclusion criteria: informed consent obtained age over 18 years diagnosis of ulcerative colitis or Crohn's colitis based on endoscopy and histology the activity of colitis confirmed by histology and/or elevated fecal calprotectin concentration fertile women have contraception no previous abdominal surgery no X-ray investtigations during preceding year Investigators Principal investigator Markku Voutilainen, MD, Department of Gastroenterology Other investigators Hannu Aronen, Sami Kajander, Johanna Virtanen, Virva Saunavaara, Department of Radiology and PET center. Mervi Tenhami, Saila Kauhanen, Department of surgery Pirjo Nuutila, Department of Endocrinology and PET center Jukka Kemppainen, physicist, PET center Olli Carpen, Department of pathology Ville Aalto, statistician, University of Turku, PET tracer is 18 F-FDG, dose 280 megabequerel (MBq, bowel imaging) Data of scans and details of scanning time (including positioning and transmission) by tracer, blood sampling (activity, metabolites) Before scanning: oral contrast intake (Mannitol dilution) 65 min Magnetic resonance imaging (MRI) positioning (prone position) 5min Abdominal MRI Scanning: 50min Region: from diaphragma to symphysis During the scan: i.v. Buscopan and +Gadolinium Sequences (fast gradient echo, predominantly breath-hold imaging): T2 (field echo type) cor and ax T2 T1 fs cor and ax +Gd T1 fs repeated (start at 40 seconds after injection) Diffusion T2 or T1 cor +aks PET, FDG tracer: 15 min Total scanning time including positioning, MRI and PET: 70 min Scanning code JN5JS (= Large scale PET-MRI of the body) Number of study subjects 45 Scanner PET/MRI The radiation dose will be calculated by physicist after the tracer, it's amount and detector are determined. The permission from ethical committee was obtained in August 2014.. No quality issues (QA), routine radiological quality control The study has been accepted by the Ethical committee of Turku University Hospital Present study is academic study and all data relating to the study belongs to the investigators. The test patients are to undergo the study in September 2014. The study is to be started October 2014. For the financing of the study, VTR-/EVO-funding (Funding from the Finnish government) will be applied. At present, 6000€ have been obtained from research funding of Department of internal medicine.

Official Title
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Combined PET-MRI in the Diagnostics of Chronic Inflammatory Bowel Diseases (IBD)- a Feasibility Study

Conditions
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IBD

Intervention / Treatment
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* Other: PET-MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria age over 18 years IBD (ulcerative colitis or Crohn's disease diagnosed by endoscopy and/or radiology no previous abdominal surgery no biological therapy for IBD Exclusion Criteria: pregnancy diabetes the patient is unable to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PET-MRI<br>Patients with chronic inflammatory bowel disease who are treated at Turku University hospital outpatient clinic or ward | Other: PET-MRI<br>* The study patients undergo positron emission tomography (PET) after informed consent is obtained<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients with active inflammation detected by PET-MRI | COMBINED PET-MRI IN THE DIAGNOSTICS AND FOLLOW-UP OF CHRONIC INFLAMMATORY BOWEL DISEASES | 3 YEARS |