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

NCT ID: NCT00731809

Last Updated: 2008-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Crohn's Disease

Keywords

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Crohn's disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

PET CT

Group Type OTHER

FDG PET CT

Intervention Type RADIATION

FDG PET CT

Interventions

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FDG PET CT

FDG PET CT

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Beilinson Hospital Rabin Medical Center

Locations

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Rabin Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Bernstine, MD

Role: primary

Other Identifiers

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004945

Identifier Type: -

Identifier Source: org_study_id