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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
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mesenteric Ischemia

Eligibility Criteria

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

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

First Posted
August 26, 2016
Last Updated
April 10, 2020
Sponsor
Poitiers University Hospital
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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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