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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00731809
• Other study ID #: 004945
• Status: Recruiting
• Phase: Phase 4
• First received: August 3, 2008
• Last updated: December 22, 2008
• Start date: April 2008
• Est. completion date: October 2010

Study information

• Verified date: February 2008
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Radiation:
• FDG PET CT
FDG PET CT

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah-tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel,