Automated Volume Assessment of Acute Stroke

Completed

• Conditions: Stroke, Software Verification, Diffusion Weighted MRI, Neuroimaging

• Registration Number: NCT03618251
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-15
• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-01
• Study First Posted: 2018-08-07
• Primary Completion: 2020-09-04
• Study Completion: 2020-12-04
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-16
• Last Update Posted: 2021-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 406

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Automated volume assessment of acute stroke	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.

Trial Locations

Locations (1)

Fondation A De Rothschild; 🇫🇷 Paris, France