PET Combined With MRI for Monitoring Inflammatory Activity in Patients With Ulcerative Colitis

Study Overview
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Brief Summary
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Colonoscopy is considered crucial for the diagnosis and quantification of ulcerative colitis (UC). However, there are several drawbacks related to the invasiveness, procedure-related discomfort, risk of bowel perforation (especially in the period of acute inflammation), and relatively poor patient acceptance. Most patients regard the necessary bowel cleansing as burdensome. Feasible, accurate and well accepted non-invasive diagnostic techniques are needed for the determination of inflammatory activity and optimal tailoring of therapy. Hybrid PET/MRI represents an innovative combination of two established, non-invasive diagnostic tools: Magnetic resonance imaging (MRI), allowing for anatomic-functional imaging of the abdomen at high soft tissue contrast and positron emission tomography (PET) utilizing 18F-fluorodeoxyglucose (FDG) a non-invasive tool to monitor glucose metabolism and allowing a detection and quantification of inflammatory processes. Since MRI has limited sensitivity in UC and may be hampered by retained stool, a combination with another imaging modality is very appealing. PET, on the other side provides functional information, yet with limited anatomical landmarks and is relatively unsusceptible to artifacts associated to retained stool. In combination, these modalities might provide a valid alternative for the non-invasive assessment of the inflammatory activity in UC patients without the need for bowel purgation. It will therefore have to be investigated whether fecal material does impede the diagnostic quality of the combination of FDG-PET and MRI. For this purpose, the investigators will include 50 patients with confirmed ulcerative colitis. Dependent on clinical activity of the inflammation, patients will be randomized to undergo PET/MRI enterography either with or without prior bowel purgation followed by a colonoscopy. Inflammatory activity in 7 bowel segments will be analyzed based on PET/MRI with and without bowel purgation with the results of colonoscopy as standard of reference. Patient acceptance of PET/MRI with and without bowel purgation as well as colonoscopy will be compared. PET/MRI with and without bowel cleansing will be compared with regard to diagnostic accuracy as well as for its patients' acceptance in comparison to colonoscopy. The investigators hypothesize that PET/MRI will eventually be highly accurate to detect and monitor inflammatory activity in patients with ulcerative colitis. Additional information about extra-intestinal findings might also change the therapeutic concept. PET/MRI might serve as a non-invasive diagnostic option in patients with UC to quantify inflammatory activity especially when bowel cleansing or colonoscopy is not applicable.

Official Title
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Positron Emission Tomography With 18F-fluorodeoxyglucose Combined With MRI for Monitoring Inflammatory Activity in Patients With Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Diagnostic Test: [18F]-FDG PET/MRI
* Diagnostic Test: Colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with confirmed ulcerative colitis verified by the defining symptoms (rectal bleeding, diarrhea), endoscopy and histopathology clinically indicated colonoscopy and 18F-FDG PET as either initial assessment or follow- up examination patient age ≥ 18 years Exclusion Criteria: Patients aged < 18years Patients with MRI contraindications, e.g. presence of cardiac pacemaker, implanted cardioverter-defibrillator, neurostimulation systems or with claustrophobia. acute renal failure, severe chronic renal failure (calculated glomerular filtration rate [GFR] < 30 ml/min) allergy to i.v. gadolinium based contrast agents

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET/MRI with bowel purgation<br> | Diagnostic Test: [18F]-FDG PET/MRI<br> <br> Diagnostic Test: Colonoscopy<br> <br> |
| Experimental: PET/MRI without bowel purgation<br> | Diagnostic Test: [18F]-FDG PET/MRI<br> <br> Diagnostic Test: Colonoscopy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of PET/MRI with and without bowel purgation | Overall segment-based diagnostic accuracy using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of PET/MRI with and without bowel purgation in percent | Overall segment-based sensitivity using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation | 24 hours | 
| Specificity of PET/MRI with and without bowel purgation in percent | Overall segment-based specificity using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation | 24 hours | 
| Negative predictive value of PET/MRI with and without bowel purgation in percent | Overall segment-based negative predictive value using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation | 24 hours | 
| Positive predictive value of PET/MRI with and without bowel purgation in percent | Overall segment-based positive predictive value using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation | 24 hours | 
| Optimized cut-offs | Optimized cut-offs for PET for each bowel segment using ileocolonoscopy as reference standard for each colon segment will be calculated | 24 hours | 
| Patient acceptance | 18F-FDG PET/MRI without bowel cleansing shows higher patient acceptance than conventional colonoscopy | 24 hours | 
| Description of extraintestinal findings | Extraintestinal findings will be assessed by evaluating PET/MRI images | 24 hours | 
| The Boston Bowel Preparation Scale | Bowel Preparation Quality will be assessed for both patient groups | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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[18F]-FDG PET/MR enterography, Diagnosis