Mesenteric IschemiaPERFE-CTNCT03367065
Dynamic Contrast Enhancement Computed Tomography Based Technic to Assess Gastro Intestinal Wall Perfusion : Feasibility Study
A study testing Dynamic contrast enhanced computerised tomography in people with Mesenteric Ischemia and Permeability CT Technics, run by Poitiers University Hospital at 1 site in France.
Trial summary
This feasibility study has therefore several aims: 1. construct a dedicated CT perfusion protocol for GIT wall perfusion; 2. used a two-compartment pharmacokinetic model which is more adapted that a unique compartment model; 3. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mesenteric Ischemia, Permeability CT Technics
- What is being tested?
- Dynamic contrast enhanced computerised tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients over fifty years old with clinico-biological suspicion for acute GITischemia admitted at our institution
Who cannot join
- contra-indication to contrast agent injection as so defined by the European Society of UroRadiology in 2014
- inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Mesenteric Ischemia, Permeability CT Technics
- Being tested
- Dynamic contrast enhanced computerised tomography
- Medical subject headings
- Mesenteric Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic contrast enhanced computerised tomographyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Dynamic contrast enhanced computerised tomography | Experimental | Not described Receives: Radiation: Dynamic contrast enhanced computerised tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of computerised tomography with interpretable data
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study startOct 2016
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesenteric IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume HERPE, MD, Principal investigator, CHU Poitiers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367065
- Sponsor's protocol ID
- PERFE-CT
- Acronym
- PERFE-CT
- Status last verified
- Apr 2020
- First submitted
- 26 Aug 2016
- Last updated
- 13 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Contrast Enhancement Computed Tomography Based Technic to Assess Gastro Intestinal Wall Perfusion : Feasibility Study
- ClinicalTrials.gov ID
- NCT03367065
- Acronym / sponsor ID
- PERFE-CT / PERFE-CT
- Conditions
- Mesenteric Ischemia, Permeability CT Technics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dynamic contrast enhanced computerised tomography | Experimental | Radiation: Dynamic contrast enhanced computerised tomography |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients over fifty years old with clinico-biological suspicion for acute GITischemia admitted at our institution
Key exclusion criteria (2 listed)
- contra-indication to contrast agent injection as so defined by the European Society of UroRadiology in 2014
- inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic contrast enhanced computerised tomography | Radiation | Dynamic contrast enhanced computerised tomography |
Primary outcome
number of computerised tomography with interpretable data
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume HERPE, MD principal investigator
CHU Poitiers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic contrast enhanced computerised tomography in people with Mesenteric Ischemia and Permeability CT Technics, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of computerised tomography with interpretable data (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020.