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Completed

NCT Number: NCT00383344

Use of FDG PET/CT to Evaluate Crohn Disease

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).

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHUS/CRC

Sherbrooke, Quebec, J1H 5N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FDG PET/CT

Procedure

Primary outcomes

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

Secondary outcomes

  1. Detection of inflammatory areas not suspected with usual tests

  2. Detection of an inflammatory activity for remission patients

Sponsors and collaborators

Lead sponsor

Eric Turcotte

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Oct 3, 2006
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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