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Automated Volume Assessment of Acute Stroke

Evaluation of Infarct Volumetric Software in Strokes of Less Than 24 Hours

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03618251
Acronym
AVAAS
Enrollment
406
Registered
2018-08-07
Start date
2018-03-15
Completion date
2020-12-04
Last updated
2021-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Software Verification, Diffusion Weighted MRI, Neuroimaging

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTspecific MRI sequences

MRI with B 2000 of diffusion weighted imaging and the coefficient of apparent diffusion

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Automated volume assessment of acute stroke1 hourOur 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026