Positron Emission Tomography (PET)-Computed Tomography (CT) in Inflammatory Bowel Disease (IBD)
Primary Purpose
Inflammatory Bowel Diseases
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
PET-CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Inflammatory Bowel Diseases
Eligibility Criteria
Inclusion Criteria: Patient with either Crohn's disease or ulcerative colitis whose disease is flaring Exclusion Criteria: Indeterminate diagnosis, pregnant, breastfeeding, or other contraindication to PET-CT
Sites / Locations
- University of Wisconsin
Outcomes
Primary Outcome Measures
Does this technique provide an accurate assessment of disease inflammation compared to standard clinical markers?
Secondary Outcome Measures
Does this technique provide additional information for practitioners on extent of disease?
Full Information
NCT ID
NCT00205062
First Posted
September 13, 2005
Last Updated
October 1, 2015
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT00205062
Brief Title
Positron Emission Tomography (PET)-Computed Tomography (CT) in Inflammatory Bowel Disease (IBD)
Official Title
Pilot Study of the Role of PET-CT for Diagnosis and Assessment of Therapeutic Efficacy in Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Terminated
Why Stopped
No Accrual
Study Start Date
October 2004 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
5. Study Description
Brief Summary
The main hypothesis is that PET-CT will be a valuable diagnostic tool in diagnosing and evaluating treatment for IBD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
PET-CT
Primary Outcome Measure Information:
Title
Does this technique provide an accurate assessment of disease inflammation compared to standard clinical markers?
Secondary Outcome Measure Information:
Title
Does this technique provide additional information for practitioners on extent of disease?
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with either Crohn's disease or ulcerative colitis whose disease is flaring
Exclusion Criteria:
Indeterminate diagnosis, pregnant, breastfeeding, or other contraindication to PET-CT
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall Meisner, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Positron Emission Tomography (PET)-Computed Tomography (CT) in Inflammatory Bowel Disease (IBD)
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