RADIOMIXSTROKE: Computational Medical Imaging and Prediction of Diffusion/FLAIR Mismatch in Stroke Patients

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05192161
Collaborator
(none)
100
2
3.5
50
14.2

Study Details

Study Description

Brief Summary

Stroke is a public health issue and a priority for our institution. MRI plays an essential role in the management of stroke. In this context, the contribution of MRI is diagnostic, etiological and prognostic.

Among the MRI parameters evaluated in the acute phase of the stroke, the evaluation of the mismatch between the DIFFUSION and FLAIR sequences is crucial as it will directly contribute to the therapeutic decision. A FLAIR-diffusion mismatch, i.e., a lesion with a diffusion but not a FLAIR hypersignal, identifies patients whose time of onset of symptoms is probably less than 4.5 hours. It is therefore understandable that the main arterial recanalization techniques performed in the acute phase are primarily reserved for patients with a positive mismatch.

In current practice, mismatch assessment is performed subjectively, by visually comparing the two sequences, which is known to be the cause of a lack of reproducibility and diagnostic performance.

Computational medical imaging techniques ("radiomics") have recently gained momentum and offer the prospect of automated and therefore more reproducible analysis of medical imaging data. In stroke patients, radiomics extracted from FLAIR imaging could thus contribute to describe the "diffusion flair" mismatch in a continuous and objective way.

For the time being, data analysis cannot be performed in real time due to technical constraints. If it is proven that radiomics can reliably analyze the mismatch on the FLAIR sequence alone, the next step will be to make the analysis feasible in clinical routine (i.e. in a time frame adapted to the therapeutic management).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Computational Medical Imaging (Radiomics) and Prediction of Diffusion/FLAIR Mismatch in Stroke Patients
    Anticipated Study Start Date :
    Sep 15, 2022
    Anticipated Primary Completion Date :
    Oct 15, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. ability of a computational medical imaging technique ("radiomics"), performed on the FLAIR sequence alone, to predict the FLAIR diffusion mismatch in patients with ischemic stroke [Day 1]

      This outcome corresponds to FLAIR / Diffusion mismatch scores estimated with both techniques: automated and visual analysis.

    Secondary Outcome Measures

    1. Inter-technique comparison of mismatch assessment between automated "radiomics" analysis and subjective visual analysis (currently performed in clinical routine) [Day 1]

      This outcome corresponds to the reproducibility and inter-technical agreement on the extent of the mismatch.

    2. Evaluation of the prognostic value of the scores obtained with the two methods [Month 3]

      This outcome corresponds to the correlation of the scores obtained with the Rankin score at 3 months.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient with age ≥ 18 years

    • Patient with supra-tentorial stroke treated by mechanical thrombectomy and who had MRI imaging on admission before endovascular treatment at Paris Saint-Joseph Hospital

    • Complete MRI protocol including Diffusion and FLAIR sequences

    • French-speaking patient

    Exclusion Criteria:
    • Patient under guardianship or curatorship

    • Patient deprived of liberty

    • Patient under court protection

    • Patient objecting to the use of his data for this research

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU Lille Lille France
    2 Groupe Hospitalier Paris Saint-Joseph Paris France 75014

    Sponsors and Collaborators

    • Groupe Hospitalier Paris Saint Joseph

    Investigators

    • Principal Investigator: Jerome HODEL, MD, Groupe Hospitalier Paris Saint Joseph

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Groupe Hospitalier Paris Saint Joseph
    ClinicalTrials.gov Identifier:
    NCT05192161
    Other Study ID Numbers:
    • RADIOMIXSTROKE
    First Posted:
    Jan 14, 2022
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 30, 2022