Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-05 @ 1:11 AM
Study NCT ID:
NCT05357833
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2022-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Imaging Markers in SPMS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020528', 'term': 'Multiple Sclerosis, Chronic Progressive'}, {'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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052203', 'term': 'Ferrosoferric Oxide'}, {'id': 'C062402', 'term': 'gadoteridol'}], 'ancestors': [{'id': 'D005290', 'term': 'Ferric Compounds'}, {'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005296', 'term': 'Ferrous Compounds'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-24', 'studyFirstSubmitDate': '2022-04-25', 'studyFirstSubmitQcDate': '2022-05-01', 'lastUpdatePostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Signal change on T1-weighted and 3D UTE MRI brain (and upper cervical cord) before and 96 hours (±24 hours) after ferumoxytol administration', 'timeFrame': '96 hours ±24 hours'}], 'secondaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events (safety and tolerability)', 'timeFrame': '96 hours ±24 hours', 'description': 'Assess the safety and tolerability of ferumoxytol in Secondary Progressive MS cohort based on Adverse Events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Perilesional microglia', 'Ferumoxytol', 'USPIO', 'Utrasmall superparamagnetic iron oxide nanoparticles', 'Infiltrating macrophages', 'Activated microglia', 'USPIO enhancement'], 'conditions': ['Secondary Progressive Multiple Sclerosis', 'Multiple Sclerosis, Secondary Progressive', 'Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This pilot study takes the innovative approach of using ultrasmall superparamagnetic iron oxide (USPIO) nanoparticle enhanced MRI to measure activity of the innate immune system within MS lesions. Activity of innate immunity has been hypothesized as one of the critical pathologic processes underpinning neurologic worsening in progressive MS. As such, in the short term this project proposes to investigate USPIO uptake in SPMS lesions as a promising in vivo imaging biomarker for chronic-active lesions, as distinguished from chronic-inactive lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults age 35 to 65 years\n2. Clinically diagnosed with secondary progressive multiple sclerosis (SPMS) (2017 McDonald Criteria)\n3. Worsening 25 foot walk time (worsening SPMS cohort) over the preceding 2 years.\n4. Ambulatory with ability to walk at least 20 meters without rest, with or without aid\n5. Ability and willingness to attend study visits and complete the study\n\nExclusion Criteria:\n\n1. Clinically diagnosed with relapsing remitting multiple sclerosis (RRMS), primary progressive multiple sclerosis (PPMS), clinical isolated syndrome (CIS), or radiologically isolated syndrome (RIS)\n2. Clinical MS relapse and/or new MRI lesion(s) within the preceding 2 years\n3. Positive pregnancy test\n4. Gadolinium contrast allergy\n5. Acute or chronic kidney disease with eGFR \\<30 ml/min/1.73m2\n6. Pacemaker or other MRI contraindications per American College of Radiology guidelines\n7. Intravenous iron sensitivity\n8. Serum ferritin and transferrin saturation above age-adjusted upper limit of normal (if serum ferritin is above normal, but transferrin saturation is normal, the subject is NOT excluded)'}, 'identificationModule': {'nctId': 'NCT05357833', 'briefTitle': 'Novel Imaging Markers in SPMS', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Novel Imaging Markers of Innate Immune Activation in Secondary Progressive Multiple Sclerosis', 'orgStudyIdInfo': {'id': '00147230'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SPMS Cohort', 'description': 'Subjects will undergo MR imaging of the brain and cervical spine for pre- and post-administration of gadoteridol (0.2 mL/kg), then pre- and post-administration of ferumoxytol (4 mg/kg). Scans will be obtained over the course of two separate imaging visits.', 'interventionNames': ['Drug: Ferumoxytol infusion', 'Drug: Gadoteridol', 'Diagnostic Test: MRI Brain and Cervical Spine']}], 'interventions': [{'name': 'Ferumoxytol infusion', 'type': 'DRUG', 'otherNames': ['Feraheme'], 'description': 'Subjects will receive a single, weighted dose of intravenous ferumoxytol (4 mg/kg) diluted in 50 mL of saline.', 'armGroupLabels': ['SPMS Cohort']}, {'name': 'Gadoteridol', 'type': 'DRUG', 'otherNames': ['ProHance, gadolinium-based MRI contrast agent'], 'description': 'Subjects will receive a single, weighted dose of intravenous gadoteridol (0.2 mL/kg).', 'armGroupLabels': ['SPMS Cohort']}, {'name': 'MRI Brain and Cervical Spine', 'type': 'DIAGNOSTIC_TEST', 'description': '3T MR imaging of the brain and cervical spine pre- and post-administration of gadolinium, then pre- and 96 hours (±24 hours) post-administration of ferumoxytol', 'armGroupLabels': ['SPMS Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Health Imaging and Neurosciences Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'M. Mateo Paz Soldan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Department of Neurology, Division of Neuroimmunology', 'investigatorFullName': 'M. Mateo Paz Soldan', 'investigatorAffiliation': 'University of Utah'}}}}