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Evaluation of PET CT in the Management of Patients With Crohn's Disease.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2008 by Rabin Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00731809
First Posted: August 11, 2008
Last Update Posted: December 23, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rabin Medical Center
  Purpose
18F-FDG PET/CT (2-[fluorine-18] fluoro-2-deoxy-D-glucose, Positron emission tomography- CT) is a noninvasive technique that allows quantifying and precisely localizing 18F-FDG uptake in the entire body. 18F-FDG uptake is caused by increased local metabolic activity. Such increased uptake has been described not only in neoplastic lesions but also in inflammatory lesions. In this condition, uptake has been correlated with local stimulation of tumor necrosis factor, and with monocyte priming and activation. A physiologic variable uptake may be observed in the bowel, especially the cecum, and has limited the use of PET in inflammatory bowel diseases. The advantage of combined PET and CT devices lead to significant improvements in the interpretation of the bowel areas, and greatly reduces the number of false-positive findings in the gastrointestinal tract.

Condition Intervention Phase
Crohn's Disease Radiation: FDG PET CT Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of PET CT in the Management of Patients With Crohn's Disease.

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Estimated Enrollment: 50
Study Start Date: April 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
PET CT
Radiation: FDG PET CT
FDG PET CT

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients suspicious for active disease:

    • Patients with suspected but undiagnosed Crohn's disease
    • Patients with serological markers of inflammation (elevated ESR, CRP or thrombocytosis) but clinically in remission
    • Patients with a stricture which might be fibrous in which case surgery is indicated or inflammatory for which medical management is indicated
    • Able to sign a consent form

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding
  • Infectious colitis determined at the initial checkup
  • Allergy to iodine contrast
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731809


Locations
Israel
Rabin Medical Center Recruiting
Petah-tikva, Israel, 49100
Contact: Bernstine, MD       hannab2@clalit.org.il   
Principal Investigator: Hanna Bernstine, MD         
Sponsors and Collaborators
Rabin Medical Center
  More Information

Responsible Party: Hanna Brrnstine MD, Beilinson Hospital Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00731809     History of Changes
Other Study ID Numbers: 004945
First Submitted: August 3, 2008
First Posted: August 11, 2008
Last Update Posted: December 23, 2008
Last Verified: February 2008

Keywords provided by Rabin Medical Center:
Crohn's disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases


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