- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07199920
- Original Trial
Implementation of New Multimodal MRI Sequences by Fingerprint to Improve Ischemic Stroke Examination. (INDEX)
Implementation of New Multimodal MRI Sequences by Fingerprint to Improve Ischemic Stroke Examination, a Pilot Study and Proof of Concept
Currently, standard brain MRI takes 20 to 25 minutes, but in the case of ischemic stroke, every minute counts to limit the extension of the necrotic core, with the possibility of recanalizing the occluded artery (intravenous thrombolysis and/or mechanical thrombectomy).
The recent concept of MRI "Fingerprint" (Magnetic Resonance Fingerprinting, MRF) allows the production of a rapid single sequence and the extraction of numerous parameters.
Demonstrating the feasibility and interpretability of multimodal MRI images acquired in MRF would make it possible to consider implementing and, ultimately, replacing conventional sequences, with the aim of shortening acute stroke management times, increasing the number of sequences acquired within a short timeframe (by increasing informativeness), and thus improving patients' short and long-term vital and functional prognosis.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zaza Putkaradze, Dr
- Phone Number: 0476767842
- Email: zputkaradze@chu-grenoble.fr
Study Locations
-
-
-
Grenoble, France, 38043
- CHU Grenoble Alpes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age > 18 years
- Subacute ischemic stroke patients (< 15 days after onset)
- Middle cerebral artery or anterior cerebral artery territory stroke
- Modified Rankin Scale (mRS) = 0-4
Exclusion Criteria:
* MRI contraindications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
Every patient will perform classic brain MRI with additional MRF sequences.
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Classic and MRF sequences will be carried out on the clinical machine (Achieva 3.0T dStream Philips) of the IRMaGe platform (CHUGA, Université Grenoble Alpes, Inserm, CNRS).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Success rate and interpretability of images acquired in MRF
Time Frame: From enrollment to the end of the MRI exam
|
Assessment of the success rate and interpretability (subjective evaluation with Likert scales of very satisfactory, satisfactory, insufficient, or unacceptable)
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From enrollment to the end of the MRI exam
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Characterize and extract the physical parameters of the signal acquired with MRF.
Time Frame: From enrollment to the end of the MRI exam
|
Comparison of MRF imaging metrics: signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR), using mean values per ROI (region of interest). Segmentation and comparison of lesions, with calculation of the Dice similarity coefficient and/or SSIM (Structural SIMilarity). Visualization and description of artifacts encountered during acquisition (e.g., motion). Quantification of delays: Acquisition time: retrieval of raw data directly from MRI consoles. Reconstruction time: measurement of computation times. Extraction of information on cerebral microvas |
From enrollment to the end of the MRI exam
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Loïc LEGRIS, Dr, llegris@chu-grenoble.fr
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC23.0410
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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