Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-30 @ 3:34 AM
Study NCT ID:
NCT06961604
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-08
First Post:
2025-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Novel Method for Determination of Thromboembolic Stroke Origin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2025-05-06', 'studyFirstSubmitQcDate': '2025-05-06', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Culprit lesion', 'timeFrame': 'Within 14 days of the stroke', 'description': 'Can NaF PET-CT within 14 days of a non-cardiogenic thromboembolic stroke identify the likely culprit plaque as a source of the stroke'}], 'secondaryOutcomes': [{'measure': 'Recurrent stroke', 'timeFrame': 'Within 1 year of imaging', 'description': 'Can NaF PET-CT within 14 days of a non-cardiogenic thromboembolic stroke predict the location of a future non-cardiogenic thromboembolic stroke'}, {'measure': 'Management change', 'timeFrame': 'Within 1 year of imaging', 'description': 'Can NaF PET-CT within 14 days of a non-cardiogenic thromboembolic stroke alter patient management'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thromboembolic Stroke']}, 'descriptionModule': {'briefSummary': 'Rupture of vulnerable carotid, vertebral, and intracranial arterial plaques results in thromboembolic stroke. Identification of these culprit lesions is an important component of post-stroke care. This study seeks to test the feasibility of NaF PET-CT to detect these plaques and alter patient care. Prior studies have shown a high degree of correlation between NaF PET+ lesions and high-risk plaque features on high resolution MRI, including mirocalcification, necrosis, and ulceration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: 18 years of age or older with a non-cardiogenic thromboembolic stroke in the past 14 days.\n\nExclusion Criteria: Less than 18 years of age, any other kind of stroke, not clinically stable to undergo PET-CT'}, 'identificationModule': {'nctId': 'NCT06961604', 'briefTitle': 'A Novel Method for Determination of Thromboembolic Stroke Origin', 'organization': {'class': 'OTHER', 'fullName': 'Atlantic Health System'}, 'officialTitle': 'A Novel Method for Determination of Thromboembolic Stroke Origin', 'orgStudyIdInfo': {'id': '2323793-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention - NaF PET', 'description': 'Intervention/Experimental Arm - non-cardiogenic thromboembolic stroke patients to undergo NaF PET-CT', 'interventionNames': ['Drug: NaF PET-CT']}], 'interventions': [{'name': 'NaF PET-CT', 'type': 'DRUG', 'description': 'Following a non-cardiogenic thromboembolic stroke, patients will undergo NaF PET-CT imaging to identify the culprit plaque and any other vulnerable plaques at high risk for rupture', 'armGroupLabels': ['Intervention - NaF PET']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07901', 'city': 'Summit', 'state': 'New Jersey', 'country': 'United States', 'contacts': [{'name': 'James Cassuto, MD, PhD', 'role': 'CONTACT', 'email': 'james.cassuto@atlantichealth.org', 'phone': '908-522-2337'}, {'name': 'James Cassuto, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Overlook Medical Center', 'geoPoint': {'lat': 40.71562, 'lon': -74.36468}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atlantic Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'jcassuto', 'investigatorAffiliation': 'Atlantic Health System'}}}}