ClinicalTrials.gg
Status unknownNCT05192161RADIOMIXSTROKEUpdated Sep 13, 2023

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

An observational study in Stroke, sponsored by Fondation Hôpital Saint-Joseph. Status unknown at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by Fondation Hôpital Saint-Joseph · Observational

The sponsor has not verified this record recently (last verified Sep 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
35
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Stroke

Browse trials for

03

In context

Stroke

7,443 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's planned enrollment of 35 is below the median of 160 across 1,729 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Fondation Hôpital Saint-Joseph is the lead sponsor of 344 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients referred for suspected stroke between January 1, 2016 and May 1, 2021 at Paris Saint Joseph Hospital.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
35 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  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

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

    Time frame: Day 1

Secondary outcomes

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

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

    Time frame: Day 1

  2. Evaluation of the prognostic value of the scores obtained with the two methods

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

    Time frame: Month 3

07

Study locations

2 sites
  • CHRU Lille
    Lille, France
  • Groupe Hospitalier Paris Saint-Joseph
    Paris, 75014, France
08

References and documents

Publications

  • Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; American Heart Association Stroke Council. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018 Mar;49(3):e46-e110. doi: 10.1161/STR.0000000000000158. Epub 2018 Jan 24. PubMed 29367334 ↗
  • Thomalla G, Cheng B, Ebinger M, Hao Q, Tourdias T, Wu O, Kim JS, Breuer L, Singer OC, Warach S, Christensen S, Treszl A, Forkert ND, Galinovic I, Rosenkranz M, Engelhorn T, Kohrmann M, Endres M, Kang DW, Dousset V, Sorensen AG, Liebeskind DS, Fiebach JB, Fiehler J, Gerloff C; STIR and VISTA Imaging Investigators. DWI-FLAIR mismatch for the identification of patients with acute ischaemic stroke within 4.5 h of symptom onset (PRE-FLAIR): a multicentre observational study. Lancet Neurol. 2011 Nov;10(11):978-86. doi: 10.1016/S1474-4422(11)70192-2. Epub 2011 Oct 4. PubMed 21978972 ↗
  • Qiu W, Kuang H, Nair J, Assis Z, Najm M, McDougall C, McDougall B, Chung K, Wilson AT, Goyal M, Hill MD, Demchuk AM, Menon BK. Radiomics-Based Intracranial Thrombus Features on CT and CTA Predict Recanalization with Intravenous Alteplase in Patients with Acute Ischemic Stroke. AJNR Am J Neuroradiol. 2019 Jan;40(1):39-44. doi: 10.3174/ajnr.A5918. Epub 2018 Dec 20. PubMed 30573458 ↗
  • Chen Q, Xia T, Zhang M, Xia N, Liu J, Yang Y. Radiomics in Stroke Neuroimaging: Techniques, Applications, and Challenges. Aging Dis. 2021 Feb 1;12(1):143-154. doi: 10.14336/AD.2020.0421. eCollection 2021 Feb. PubMed 33532134 ↗
  • Tang TY, Jiao Y, Cui Y, Zhao DL, Zhang Y, Wang Z, Meng XP, Yin XD, Yang YJ, Teng GJ, Ju SH. Penumbra-based radiomics signature as prognostic biomarkers for thrombolysis of acute ischemic stroke patients: a multicenter cohort study. J Neurol. 2020 May;267(5):1454-1463. doi: 10.1007/s00415-020-09713-7. Epub 2020 Feb 1. PubMed 32008072 ↗
  • Feng R, Badgeley M, Mocco J, Oermann EK. Deep learning guided stroke management: a review of clinical applications. J Neurointerv Surg. 2018 Apr;10(4):358-362. doi: 10.1136/neurintsurg-2017-013355. Epub 2017 Sep 27. PubMed 28954825 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05192161
Responsible party
Sponsor
First posted
Jan 14, 2022
Start date
Apr 5, 2023
Primary completion
May 5, 2023
Completion
Dec 31, 2023 (estimated)
Last update
Sep 13, 2023

Study contacts

Jerome HODEL, MD
principal investigator · Fondation Hôpital Saint-Joseph

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion