NCT00383344

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

7 months

First QC Date

October 2, 2006

Last Update Submit

December 4, 2024

Conditions

Crohn Disease

Keywords

Crohn DiseasePositron Emission TomographyColonoscopy

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of Crohn Disease de novo and Crohn Disease recurrences with FDG PET/CT.

Secondary Outcomes (2)

  • Detection of inflammatory areas not suspected with usual tests

  • Detection of an inflammatory activity for remission patients

Interventions

FDG PET/CTPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUS/CRC

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • François Bénard, MD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 2, 2006

First Posted

October 3, 2006

Study Start

October 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

December 9, 2024

Record last verified: 2024-12

Locations

CA(1)