Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:25 AM
Study NCT ID:
NCT07444034
Status:
RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study of a Portable Head-Only MRI Scanner
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-02-24', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Image Quality', 'timeFrame': 'Day 1', 'description': 'The study will quantitatively compare images obtained at 0.7 Tesla (obtained with new methods and instrumentation) with images obtained with conventional MRI. The metrics to be assessed include: spatial resolution, signal-to-noise ratio, signal-to-artifact ratio, contrast-to-noise ratio, and geometric distortion.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Brain Imaging']}, 'descriptionModule': {'briefSummary': 'This is a pilot study to demonstrate human brain imaging with a new portable 0.7 Tesla (T) MRI brain scanner recently developed at the CMRR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Able to consent for themselves\n* Free of contraindications for MRI\n\nExclusion Criteria:\n\n* Currently pregnant\n* Extremely claustrophobic'}, 'identificationModule': {'nctId': 'NCT07444034', 'briefTitle': 'A Pilot Study of a Portable Head-Only MRI Scanner', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'A Pilot Study of a Portable Head-Only MRI Scanner', 'orgStudyIdInfo': {'id': 'CMRR-2025-33869'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.7 T MRI', 'interventionNames': ['Device: 0.7 T MRI']}], 'interventions': [{'name': '0.7 T MRI', 'type': 'DEVICE', 'description': 'Our scanner is based on a unique high-temperature superconducting magnet that is highly compact, weighs only 400 kg, and requires no cryogens. Its innovative design allows the subject to sit normally with sightlines to the room and produces low acoustic noise during scanning.', 'armGroupLabels': ['0.7 T MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'centralContacts': [{'name': 'Michael Garwood, PhD', 'role': 'CONTACT', 'email': 'gar@umn.edu', 'phone': '612-626-2001'}, {'name': 'Sarah Bedell', 'role': 'CONTACT', 'email': 'sbedell@umn.edu'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}