Use of FDG PET/CT to Evaluate Crohn Disease

Study Overview
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Brief Summary
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The purpose of this study will permit to determine the role of FDG PET/CT to diagnose Crohn Disease and recurrence of Crohn disease after having compared results of PET/CT's with results of exams routinely performed(colonoscopy and bowel follow through).

Detailed Description
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Crohn disease is an inflammatory disease of the digestive system that may affect the small and large intestines. Remission and recurrence clinically characterized its development. When recurrence occurs, a careful examination is necessary in order to determine the extent and the severity of the disease. Actual exams performed are invasive and uncomfortable(colonoscopy and bowel follow through). Compare to these exams, PET/CT is less fierce to undergo and has less risks. Two groups are proposed in this project: 15 patients will be enroll in the active disease group and 15 patients will be enroll in the remission group. In regards of the area and the extent of the disease,PET/CT exams shall provide similar information than what usual tests provide. PET/CT exams shall also provide more information in order to better differentiate inflammatory stenosis from scars stenosis especially located in the small intestine.

Official Title
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Phase II Study on the Role of the Positron Emission Tomography Combined With CT Scan for the Evaluation on Crohn Disease

Conditions
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Crohn Disease

Intervention / Treatment
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* Procedure: FDG PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women known having a Crohn's disease de novo diagnosis or a Crohn's disease recurrence based on a seven days questionnaire and a physical exam. Men or women with a past history of Crohn's disease but considered clinically in remission based on a seven days questionnaire, a physical exam and a Crohn's disease activity index (CDAI) score < to 150. Exclusion Criteria: Men or women less than 18 years of age Pregnancy Breastfeeding Renal failure Suspicion of a Crohn's disease infectious complication (abscess,fistula) Infectious colitis determined at the initial checkup Diabetes Severe allergy to iode contrast

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: FDG PET/CT|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of Crohn Disease de novo and Crohn Disease recurrences with FDG PET/CT. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of inflammatory areas not suspected with usual tests |  |  | 
| Detection of an inflammatory activity for remission patients |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn Disease, Positron Emission Tomography, Colonoscopy