Dynamic Contrast Enhancement Computed Tomography Based Technic to Assess Gastro Intestinal Wall Perfusion : Feasibility Study (PERFE-CT)
Primary Purpose
Mesenteric Ischemia, Permeability CT Technics
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dynamic contrast enhanced computerised tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Mesenteric Ischemia
Eligibility Criteria
Inclusion Criteria:
- all patients over fifty years old with clinico-biological suspicion for acute GITischemia admitted at our institution
Exclusion Criteria:
- contra-indication to contrast agent injection as so defined by the European Society of UroRadiology in 2014
- inability to provide informed consent
Sites / Locations
- Chu Poitiers
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dynamic contrast enhanced computerised tomography
Arm Description
Outcomes
Primary Outcome Measures
number of computerised tomography with interpretable data
Secondary Outcome Measures
Full Information
NCT ID
NCT03367065
First Posted
August 26, 2016
Last Updated
April 10, 2020
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03367065
Brief Title
Dynamic Contrast Enhancement Computed Tomography Based Technic to Assess Gastro Intestinal Wall Perfusion : Feasibility Study
Acronym
PERFE-CT
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
5. Study Description
Brief Summary
This feasibility study has therefore several aims:
construct a dedicated CT perfusion protocol for GIT wall perfusion;
used a two-compartment pharmacokinetic model which is more adapted that a unique compartment model;
from the image acquired, evaluate current parameters of perfusion including the permeability ones
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesenteric Ischemia, Permeability CT Technics
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dynamic contrast enhanced computerised tomography
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Dynamic contrast enhanced computerised tomography
Primary Outcome Measure Information:
Title
number of computerised tomography with interpretable data
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all patients over fifty years old with clinico-biological suspicion for acute GITischemia admitted at our institution
Exclusion Criteria:
contra-indication to contrast agent injection as so defined by the European Society of UroRadiology in 2014
inability to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume HERPE, MD
Organizational Affiliation
CHU Poitiers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Poitiers
City
Poitiers
State/Province
Aquitaine
ZIP/Postal Code
86000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Dynamic Contrast Enhancement Computed Tomography Based Technic to Assess Gastro Intestinal Wall Perfusion : Feasibility Study
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