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Use of FDG PET/CT to Evaluate Crohn Disease

Primary Purpose

Crohn Disease

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
FDG PET/CT
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Crohn Disease focused on measuring Crohn Disease, Positron Emission Tomography, Colonoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHUS/CRCRecruiting

Outcomes

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

Full Information

First Posted
October 2, 2006
Last Updated
April 5, 2007
Sponsor
Université de Sherbrooke
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1. Study Identification

Unique Protocol Identification Number
NCT00383344
Brief Title
Use of FDG PET/CT to Evaluate Crohn Disease
Official Title
Phase II Study on the Role of the Positron Emission Tomography Combined With CT Scan for the Evaluation on Crohn Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Université de Sherbrooke

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
Crohn Disease, Positron Emission Tomography, Colonoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
FDG PET/CT
Primary Outcome Measure Information:
Title
Diagnosis of Crohn Disease de novo and Crohn Disease recurrences with FDG PET/CT.
Secondary Outcome Measure Information:
Title
Detection of inflammatory areas not suspected with usual tests
Title
Detection of an inflammatory activity for remission patients

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François Bénard, Doctor
Phone
819 346-1110
Ext
11898
Email
francois.benard@usherbrooke.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Chantal Langevin, RN
Phone
819 346-1110
Ext
12887
Email
chantal.langevin@chus.qc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Bénard, MD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUS/CRC
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Bénard, DR
Phone
819 346-1110
Ext
11868
Email
francois.benard@usherbrooke.ca
First Name & Middle Initial & Last Name & Degree
Chantal Langevin, RN, coordinator
Phone
819 346-1110
Ext
12887
Email
chantal.langevin@chus.qc.ca
First Name & Middle Initial & Last Name & Degree
François Bénard, DR
First Name & Middle Initial & Last Name & Degree
Serge Langevin, DR
First Name & Middle Initial & Last Name & Degree
Vivianne Bergeron, DR
First Name & Middle Initial & Last Name & Degree
Gerard Schmutz, DR
First Name & Middle Initial & Last Name & Degree
Eric Turcotte, DR

12. IPD Sharing Statement

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Use of FDG PET/CT to Evaluate Crohn Disease

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