Stroke, Software Verification, Diffusion Weighted MRI, Neuroimaging Clinical Trial
— AVAASOfficial title:
Evaluation of Infarct Volumetric Software in Strokes of Less Than 24 Hours
| NCT number | NCT03618251 |
| Other study ID # | FCD_2017_20 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 15, 2018 |
| Est. completion date | December 4, 2020 |
| Verified date | September 2021 |
| Source | Fondation Ophtalmologique Adolphe de Rothschild |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 406 |
| Est. completion date | December 4, 2020 |
| Est. primary completion date | September 4, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Fondation A De Rothschild | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Fondation Ophtalmologique Adolphe de Rothschild |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |
1 hour |