Use of FDG PET/CT to Evaluate Crohn Disease - Full Text View

Sponsored by:	Universitaire de Sherbrooke
Information provided by:	Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:	NCT00383344

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 II

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Phase II Study on the Role of the Positron Emission Tomography Combined With CT Scan for the Evaluation on Crohn Disease

Further study details as provided by Universitaire 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Universitaire de Sherbrooke

Investigators

Principal Investigator:

François Bénard, MD

Université de Sherbrooke

More Information

Study ID Numbers:	06-086
Study First Received:	October 2, 2006
Last Updated:	April 5, 2007
ClinicalTrials.gov Identifier:	NCT00383344
Health Authority:	Canada: Health Canada

Keywords provided by Universitaire de Sherbrooke:

Crohn Disease
Positron Emission Tomography
Colonoscopy

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

ClinicalTrials.gov processed this record on January 14, 2009