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Use of FDG PET/CT to Evaluate Crohn Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2006 by Université de Sherbrooke.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00383344
First Posted: October 3, 2006
Last Update Posted: April 6, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Université de Sherbrooke
  Purpose
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).

Condition Intervention Phase
Crohn Disease Procedure: FDG PET/CT Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase II Study on the Role of the Positron Emission Tomography Combined With CT Scan for the Evaluation on Crohn Disease

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Diagnosis of Crohn Disease de novo and Crohn Disease recurrences with FDG PET/CT.

Secondary Outcome Measures:
  • Detection of inflammatory areas not suspected with usual tests
  • Detection of an inflammatory activity for remission patients

Estimated Enrollment: 30
Study Start Date: September 2006
Estimated Study Completion Date: May 2007
Detailed Description:
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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00383344


Contacts
Contact: François Bénard, Doctor 819 346-1110 ext 11898 francois.benard@usherbrooke.ca
Contact: Chantal Langevin, RN 819 346-1110 ext 12887 chantal.langevin@chus.qc.ca

Locations
Canada, Quebec
CHUS/CRC Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: François Bénard, DR    819 346-1110 ext 11868    francois.benard@usherbrooke.ca   
Contact: Chantal Langevin, RN, coordinator    819 346-1110 ext 12887    chantal.langevin@chus.qc.ca   
Principal Investigator: François Bénard, DR         
Principal Investigator: Serge Langevin, DR         
Principal Investigator: Vivianne Bergeron, DR         
Sub-Investigator: Gerard Schmutz, DR         
Sub-Investigator: Eric Turcotte, DR         
Sponsors and Collaborators
Université de Sherbrooke
Investigators
Principal Investigator: François Bénard, MD Université de Sherbrooke
  More Information

ClinicalTrials.gov Identifier: NCT00383344     History of Changes
Other Study ID Numbers: 06-086
First Submitted: October 2, 2006
First Posted: October 3, 2006
Last Update Posted: April 6, 2007
Last Verified: October 2006

Keywords provided by Université de Sherbrooke:
Crohn Disease
Positron Emission Tomography
Colonoscopy

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases


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