Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2026-01-04 @ 11:43 PM
Study NCT ID:
NCT06452459
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glymphatic MRI Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012892', 'term': 'Sleep Deprivation'}], 'ancestors': [{'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-05', 'studyFirstSubmitDate': '2024-06-05', 'studyFirstSubmitQcDate': '2024-06-05', 'lastUpdatePostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contrast enhancement', 'timeFrame': '2 weeks', 'description': 'Measurement of contrast intensity in brain parenchyma'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Deprivation']}, 'descriptionModule': {'briefSummary': 'This study aims at identifying neuroimaging markers of glymphatic function in humans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adults', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to undergo MRI without anesthesia\n* Calculated GFR greater or equal to 60 mL/min/1.73 m2\n\nExclusion Criteria:\n\n* Inability to obtain consent\n* Subject is incarcerated, pregnant, or lactating or suspects they may be pregnant\n* Known allergic or hypersensitivity reactions to gadolinium\n* Three or more drug allergies from separate drug classes\n* Recent or expected beed for imaging with iodinated contrast\n* Contraindications to MRI: claustrophobia, weight greater than maximum MRI scanner capacity, presence of metallic foreign body, or implanted devices not documented as MRI safe\n* History of neurosurgical procedure or cervical surgery\n* Current use of anticoagulation medications\n* Contraindication to lumbar puncture (creatinine or INR elevated above laboratory standard cutoffs)'}, 'identificationModule': {'nctId': 'NCT06452459', 'briefTitle': 'Glymphatic MRI Study', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Evaluation of Glymphatic Function With MRI', 'orgStudyIdInfo': {'id': 'IT Gadolinium Study'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No interventinon', 'type': 'OTHER', 'description': 'No intervention is anticipated. This is an observational study.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Juan Piantino', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}