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

Primary Purpose

Crohn's Disease

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
FDG PET CT
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Crohn's Disease focused on measuring Crohn's disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rabin Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

PET CT

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 3, 2008
Last Updated
December 22, 2008
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00731809
Brief Title
Evaluation of PET CT in the Management of Patients With Crohn's Disease.
Official Title
Evaluation of PET CT in the Management of Patients With Crohn's Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
October 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
PET CT
Intervention Type
Radiation
Intervention Name(s)
FDG PET CT
Intervention Description
FDG PET CT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Rabin Medical Center
City
Petah-tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernstine, MD
Email
hannab2@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Hanna Bernstine, MD

12. IPD Sharing Statement

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

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