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

NCT00731809 | Unknown Phase 4 DMC

• 1 other identifier: 004945
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn's Disease

Keywords

Crohn's disease

Study Arms (1)

1

OTHER

PET CT

Radiation: FDG PET CT

Interventions

FDG PET CT RADIATION

FDG PET CT

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Breastfeeding
• Infectious colitis determined at the initial checkup
• Allergy to iodine contrast

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, 49100, Israel

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 3, 2008
• First Posted: August 11, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: October 1, 2010
• Last Updated: December 23, 2008

Record last verified: 2008-02

Locations

IL (1)