Stroke, Software Verification, Diffusion Weighted MRI, NeuroimagingAVAASNCT03618251
Automated Volume Assessment of Acute Stroke
An observational study of Stroke, Software Verification, Diffusion Weighted MRI, Neuroimaging, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Stroke is a common disease. It is increasingly managed in non-specialized centers. The volume of the lesion, evaluated on the diffusion weighted imaging, is a prognostic factor of clinical progression and is useful for the treatment decision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Software Verification, Diffusion Weighted MRI, Neuroimaging
- What is being tested?
- specific MRI sequences
- How many people
- 406 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2018to 4 Dec 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: we will include all adult patient with ischemic stroke which have MRI for stroke diagnosis
Who may be able to join
- Patients admitted for a recent neurological deficit (less than 24 hours), suspected for a stroke.
- Non inclusion criteria :
- Pregnant or breastfeeding women
- Patients with absolute contraindications to MRI
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Infarct Volumetric Software in Strokes of Less Than 24 Hours
Stroke is a common disease. It is increasingly managed in non-specialized centers.
The volume of the lesion, evaluated on the diffusion weighted imaging, is a prognostic factor of clinical progression and is useful for the treatment decision.
Read more
There is therefore a real interest in having a reliable software able to detect the stroke and evaluate the volume of the cerebral infarction. The aim is to provide rapid information to the interventional neuroradiologist and optimize the care of the patient.
The Alberta Stroke Program Early Computed Tomography Score currently used to predict response to treatment divides the territory of the middle cerebral artery. It has a few limitations, it is unreproducible and concerns only the territory of the middle cerebral artery.
Manual volumetry is a long and also not very reproducible technique. The aim of our study is to evaluate the reproducibility and diagnostic performances of the automated segmentation software based on the diffusion weighted imaging sequence, and to compare it to manual and semi-automatic measurements.
- Being tested
- specific MRI sequences
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specific MRI sequencesDiagnostic test
MRI with B 2000 of diffusion weighted imaging and the coefficient of apparent diffusion
| Study group | Role | What they receive |
|---|---|---|
| ischemic stroke | all patients with a suspicion of ischemic stroke Receives: Diagnostic Test: specific MRI sequences |
What is being measured
The primary outcome is the main question the study is designed to answer.
Automated volume assessment of acute stroke
Our objective is to compare several volumetric techniques (manual, semi-manual, automatic) based on the B 2000 of diffusion weighted imaging and the coefficient of apparent diffusion.
We will also evaluate the correlation between the volumes obtained by the different techniques and the final volume of FLAIR infarction and diffusion in a subgroup of patients for whom a follow-up MRI is feasible.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start15 Mar 2018
- Primary completion4 Sep 2020
- Study completion4 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, Software Verification, Diffusion Weighted MRI, NeuroimagingStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618251
- Sponsor's protocol ID
- FCD_2017_20
- Acronym
- AVAAS
- Status last verified
- Sep 2021
- First submitted
- 1 Aug 2018
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Infarct Volumetric Software in Strokes of Less Than 24 Hours
- ClinicalTrials.gov ID
- NCT03618251
- Acronym / sponsor ID
- AVAAS / FCD_2017_20
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 4 Sep 2020 (actual)
- Study completion
- 4 Dec 2020 (actual)
- First posted
- 7 Aug 2018 (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.
Stroke is a common disease. It is increasingly managed in non-specialized centers.
The volume of the lesion, evaluated on the diffusion weighted imaging, is a prognostic factor of clinical progression and is useful for the treatment decision.
There is therefore a real interest in having a reliable software able to detect the stroke and evaluate the volume of the cerebral infarction. The aim is to provide rapid information to the interventional neuroradiologist and optimize the care of the patient.
The Alberta Stroke Program Early Computed Tomography Score currently used to predict response to treatment divides the territory of the middle cerebral artery. It has a few limitations, it is unreproducible and concerns only the territory of the middle cerebral artery.
Manual volumetry is a long and also not very reproducible technique. The aim of our study is to evaluate the reproducibility and diagnostic performances of the automated segmentation software based on the diffusion weighted imaging sequence, and to compare it to manual and semi-automatic measurements.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ischemic stroke | – | Diagnostic Test: specific MRI sequencesall patients with a suspicion of ischemic stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- we will include all adult patient with ischemic stroke which have MRI for stroke diagnosis
Key inclusion criteria (4 listed)
- Patients admitted for a recent neurological deficit (less than 24 hours), suspected for a stroke.
- Pregnant or breastfeeding women
- Patients with absolute contraindications to MRI
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| specific MRI sequencesMRI with B 2000 of diffusion weighted imaging and the coefficient of apparent diffusion | Diagnostic test | ischemic stroke |
Primary outcome
Automated volume assessment of acute stroke
Time frame: 1 hour
Our objective is to compare several volumetric techniques (manual, semi-manual, automatic) based on the B 2000 of diffusion weighted imaging and the coefficient of apparent diffusion. We will also evaluate the correlation between the volumes obtained by the different techniques and the final volume of FLAIR infarction and diffusion in a subgroup of patients for whom a follow-up MRI is feasible.
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 17 Sep 2021.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Software Verification, Diffusion Weighted MRI, Neuroimaging, run by Fondation Ophtalmologique Adolphe de Rothschild 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 4 inclusion and 0 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 17 Sep 2021. 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?
Automated volume assessment of acute stroke (time frame: 1 hour). 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 17 Sep 2021.