Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-28 @ 11:56 AM
Study NCT ID:
NCT07037966
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-23
First Post:
2025-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advancing Portable Brain Imaging: The NextMRI Project's Role in Revolutionizing Diagnostic MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The radiologist is assessing the diagnostic outcome without knowledge of the reference scan.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "All participants receive the same intervention. There's no randomization.-the aim is to evaluate the performance of the device within the same group of patients."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2025-05-20', 'studyFirstSubmitQcDate': '2025-06-17', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiological reports to Evaluate NextMRI prototype performance', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'A clinical evaluation study will be performed involving a multidisciplinary team of radiologists, traumatologists, rheumatologists, physiotherapists, data managers and physicists.\n\nThe validation strategy will be structured in 3 steps:\n\n1. Radiologists will report the high-resolution MR images in a structured report as part of their clinical duties.\n2. Radiologists will evaluate the MR images acquired with the PR Gen III scanner after 8 weeks, in order be blind to the first reading and avoid learning interobserver bias\n3. Finally, the gold standard information obtained by the initial radiological report will serve to evaluate the prototype performance and train the Deep Learning tools.\n\nThe report documents technical details, contrast use, and lesion analysis in brain, spine, and medulla. It quantifies key MS-related lesions, categorizes locations, and notes other abnormalities. A diagnostic impression summarizes findings to support MS diagnosis.'}], 'secondaryOutcomes': [{'measure': 'Patient Comfort and Satisfaction Questionnaire to Evaluate the New NextMRI Prototype Compared to the Standard MRI Scanner', 'timeFrame': '1 year', 'description': 'Patients provide insights into their experiences with both scanners, focusing on aspects such as ease of entry and exit, comfort during positioning, perception of claustrophobia, noise levels, and overall satisfaction. Additionally, they compare the two scanners directly, offering valuable perspectives on which device they prefer and why. Their comments highlight subjective comfort and practical challenges, which are critical for improving patient-centered design.\n\nThe Questionnaire will use a Likert scale (e.g., from 1 = very uncomfortable to 5 = very comfortable) combined with open-ended questions for additional comments.'}, {'measure': 'User Comfort and Satisfaction Questionnaire Evaluate the New NextMRI Prototype Compared to the Standard MRI Scanner', 'timeFrame': '1 year', 'description': "Healthcare professionals, including radiologists and MRI technicians, evaluate the scanners from an operational standpoint. Their feedback covers ease of use, image quality, workflow efficiency, technical issues, and overall satisfaction with the device's performance. They also compare the NextMRI prototype to the standard scanner, assessing its potential impact on clinical practice, particularly for patients with conditions like Multiple Sclerosis. Professionals are asked to identify any anticipated challenges in implementation and to suggest additional training or resources needed for optimal use.\n\nThe Questionnaire will use a Likert scale (e.g., from 1 = very uncomfortable to 5 = very comfortable) combined with open-ended questions for additional comments."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multiple sclerosis', 'MRI', 'Brain Imaging'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '35907975', 'type': 'BACKGROUND', 'citation': 'Guallart-Naval T, Algarin JM, Pellicer-Guridi R, Galve F, Vives-Gilabert Y, Bosch R, Pallas E, Gonzalez JM, Rigla JP, Martinez P, Lloris FJ, Borreguero J, Marcos-Perucho A, Negnevitsky V, Marti-Bonmati L, Rios A, Benlloch JM, Alonso J. Portable magnetic resonance imaging of patients indoors, outdoors and at home. Sci Rep. 2022 Jul 30;12(1):13147. doi: 10.1038/s41598-022-17472-w.'}, {'pmid': '32627235', 'type': 'BACKGROUND', 'citation': "O'Reilly T, Teeuwisse WM, de Gans D, Koolstra K, Webb AG. In vivo 3D brain and extremity MRI at 50 mT using a permanent magnet Halbach array. Magn Reson Med. 2021 Jan;85(1):495-505. doi: 10.1002/mrm.28396. Epub 2020 Jul 5."}], 'seeAlsoLinks': [{'url': 'https://nextmri.eu/', 'label': 'Truly portable MRI for extremity and brain imaging anywhere \\& everywhere'}]}, 'descriptionModule': {'briefSummary': 'Mobile imaging diagnostic devices are extremely valuable for clinical diagnosis both inside and outside healthcare facilities. However, Magnetic Resonance Imaging (MRI)-the gold standard for diagnosing many neurological and musculoskeletal conditions-is not easily portable. Moreover, due to its high cost (in the million-euro range) and limited availability, the average wait time in Europe for an MRI scan is from several weeks to months.\n\nThe NextMRI project aims to take the technical, industrial, and commercial steps required to deploy portable low-field MRI systems in remote and developing regions, rural areas, sporting events, military or medical camps, and home healthcare settings, improving diagnostic capabilities. The specific goals of the NextMRI project are:\n\n1. Expand current low-field MRI technology to brain imaging.\n2. Enhance diagnostic accuracy using machine learning.\n3. Improve portability and usability for end users.\n4. Reduce production costs for broader affordability.\n5. Collect clinical evidence through trials to validate medical performance.\n6. Develop a sustainable business model for market commercialization.', 'detailedDescription': 'Based on this context, the NextMRI project will carry out a clinical evaluation study involving a multidisciplinary team of radiologists, rheumatologists, physiotherapists, data managers, and physicists. The study will focus on patients with suspected multiple sclerosis (MS). Its main goals are to:\n\n1. Assess the diagnostic value of the low-field MRI prototype.\n2. Evaluate usability for end users.\n3. Train AI algorithms using deep learning to differentiate between healthy and damaged tissues, thereby aiding radiologists, reducing diagnostic time, and lightening their workload.\n\nRadiologists will first generate structured reports based on standard high-resolution MRI scans. They will then evaluate the low-field MRI images from the NextMRI prototype. The initial high-field MRI reports will serve as the reference standard for assessing performance and training the AI system.\n\nEach patient will undergo two MRI scans on the same day (after providing informed consent): one at the standard 3T MR scan and other at the low-field MRI scan (NextMRI). To prevent bias, both scans will be interpreted by a professional radiologist with an 8-week interval between readings.\n\nA total of 50 patients aged between 18 and 65 years with suspected multiple sclerosis will be included. Patients with any contraindications for high-field MRI will be excluded from the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with suspected multiple sclerosis\n\nExclusion Criteria:\n\n* Any contradictions for high-field MRI'}, 'identificationModule': {'nctId': 'NCT07037966', 'briefTitle': "Advancing Portable Brain Imaging: The NextMRI Project's Role in Revolutionizing Diagnostic MRI", 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigacion Sanitaria La Fe'}, 'officialTitle': 'Truly Portable MRI for Extremity and Brain Imaging Anywhere & Everywhere', 'orgStudyIdInfo': {'id': 'NextMRI Brain Validation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with Suspected Multiple Sclerosis', 'description': 'A total of 50 patients aged between 18 and 65 years with suspected multiple sclerosis will be scanned using both the 3T MRI and the NextMRI prototype.', 'interventionNames': ['Device: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'DEVICE', 'description': 'Standard 3T MRI Scan', 'armGroupLabels': ['Patients with Suspected Multiple Sclerosis']}, {'name': 'MRI', 'type': 'DEVICE', 'description': 'Low-field MRI scan using the NextMRI prototype', 'armGroupLabels': ['Patients with Suspected Multiple Sclerosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46026', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario y Politécnico la Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': 'Paula Doria Borrell, PhD', 'role': 'CONTACT', 'email': 'paula_doria@iislafe.es', 'phone': '+34629301756'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Investigacion Sanitaria La Fe', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Council, Spain', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}