Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT07199920
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-30
First Post:
2024-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Implementation of New Multimodal MRI Sequences by Fingerprint to Improve Ischemic Stroke Examination.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2024-02-14', 'studyFirstSubmitQcDate': '2025-09-22', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate and interpretability of images acquired in MRF', 'timeFrame': 'From enrollment to the end of the MRI exam', 'description': 'Assessment of the success rate and interpretability (subjective evaluation with Likert scales of very satisfactory, satisfactory, insufficient, or unacceptable)'}], 'secondaryOutcomes': [{'measure': 'Characterize and extract the physical parameters of the signal acquired with MRF.', 'timeFrame': 'From enrollment to the end of the MRI exam', 'description': 'Comparison of MRF imaging metrics: signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR), using mean values per ROI (region of interest).\n\nSegmentation and comparison of lesions, with calculation of the Dice similarity coefficient and/or SSIM (Structural SIMilarity).\n\nVisualization and description of artifacts encountered during acquisition (e.g., motion).\n\nQuantification of delays:\n\nAcquisition time: retrieval of raw data directly from MRI consoles. Reconstruction time: measurement of computation times. Extraction of information on cerebral microvas'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRF (Magnetic Resonance Fingerprinting)', 'stroke', 'MRI'], 'conditions': ['Stroke, Ischemic']}, 'descriptionModule': {'briefSummary': '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).\n\nThe recent concept of MRI "Fingerprint" (Magnetic Resonance Fingerprinting, MRF) allows the production of a rapid single sequence and the extraction of numerous parameters.\n\nDemonstrating 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Subacute ischemic stroke patients (\\< 15 days after onset)\n* Middle cerebral artery or anterior cerebral artery territory stroke\n* Modified Rankin Scale (mRS) = 0-4\n\nExclusion Criteria:\n\n\\* MRI contraindications'}, 'identificationModule': {'nctId': 'NCT07199920', 'acronym': 'INDEX', 'briefTitle': 'Implementation of New Multimodal MRI Sequences by Fingerprint to Improve Ischemic Stroke Examination.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Implementation of New Multimodal MRI Sequences by Fingerprint to Improve Ischemic Stroke Examination, a Pilot Study and Proof of Concept', 'orgStudyIdInfo': {'id': '38RC23.0410'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Every patient will perform classic brain MRI with additional MRF sequences.', 'interventionNames': ['Device: Achieva 3.0T dStream Philips']}], 'interventions': [{'name': 'Achieva 3.0T dStream Philips', 'type': 'DEVICE', 'description': '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).', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Chu Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'centralContacts': [{'name': 'Zaza Putkaradze, Dr', 'role': 'CONTACT', 'email': 'zputkaradze@chu-grenoble.fr', 'phone': '0476767842'}], 'overallOfficials': [{'name': 'Loïc LEGRIS, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'llegris@chu-grenoble.fr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'Grenoble Institut des Neurosciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}