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Use of FDG PET/CT to Evaluate Crohn Disease

Phase II Study on the Role of the Positron Emission Tomography Combined With CT Scan for the Evaluation on Crohn Disease

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00383344
Enrollment
30
Registered
2006-10-03
Start date
2006-10-01
Completion date
2007-05-01
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

Keywords

Crohn Disease, Positron Emission Tomography, Colonoscopy

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.

Interventions

PROCEDUREFDG PET/CT

Sponsors

Eric Turcotte
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Detection of inflammatory areas not suspected with usual tests
Detection of an inflammatory activity for remission patients

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026