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Use of FDG PET/CT to Evaluate Crohn Disease

NCT ID: NCT00383344

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-01

Study Completion Date

2007-05-01

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.

Conditions

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Crohn Disease

Keywords

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Crohn Disease Positron Emission Tomography Colonoscopy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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FDG PET/CT

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eric Turcotte

OTHER

Sponsor Role lead

Responsible Party

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Eric Turcotte

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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François Bénard, MD

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

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CHUS/CRC

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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06-086

Identifier Type: -

Identifier Source: org_study_id