Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-01-29 @ 6:23 PM
Study NCT ID:
NCT01886820
Status:
UNKNOWN
Last Update Posted:
2017-07-26
First Post:
2013-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral Beta-Amyloid When Compared With Postmortem Histopathology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 290}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-25', 'studyFirstSubmitDate': '2013-06-24', 'studyFirstSubmitQcDate': '2013-06-25', 'lastUpdatePostDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of [18F]NAV4694 Brain PET scan positivity compared to histopathology', 'timeFrame': '6 Months'}], 'secondaryOutcomes': [{'measure': 'Quantification of [18F]NAV4694 brain PET Scan positivity compared to histopathology', 'timeFrame': '6 Months'}, {'measure': 'Incidence of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology', 'timeFrame': '6 Months'}, {'measure': 'Quantification of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology', 'timeFrame': '6 Months'}, {'measure': 'Incidence of adverse events', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dementia', "Alzheimer's Disease", 'Terminally Ill'], 'conditions': ['Dementia', "Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': 'To Determine the the Efficacy and Safety of \\[18F\\]NAV4694 PET for Detection of Cerebral β-Amyloid When Compared With Postmortem Histopathology'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subjects will be at least 21 years of age.\n* Subjects will have a life expectancy of approximately 6 months\n* Subject health is adequate as determined by the investigator to receive \\[18F\\]NAV4694\n* Female subjects will not be of child-bearing potential or will have a negative urine pregnancy test on day of \\[18F\\]NAV4694 injection.\n* Must exhibit adequate visual, auditory, and communication capabilities to enable compliance with study procedures. This includes being able to lie down flat in the MRI or CT and PET scanner for a period of approximately 1 hour.\n* Subjects must be willing to donate their brains for post mortem examination upon death (this consent can be obtained in the manner specific to the country/region involved).\n* Subjects have been fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA), as applicable, and informed consent or assent has been signed and dated (with time) by the subject and/or the subject's legally acceptable representative (LAR) (for individuals with dementia).\n\nExclusion Criteria:\n\n* Scheduled for surgery and/or another invasive procedure within the time period of up to 7 days after \\[18F\\]NAV4694 injection.\n* Has severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumor (metastasis/brain cancer) as verified by MRI that prohibits sampling of the required pre-specified ROIs.\n* Has any history of any transmissible spongiform encephalopathy (prion disease).\n* Has received any contrast material (X-ray, MRI) or radiopharmaceutical within 48 hours prior to, or a therapeutic radiopharmaceutical (e.g., 131-I) within 10 days prior to, or any radiopharmaceutical administration within 10 radioactive half-lives prior to the administration of the investigational product or for whom administration of such substances is planned within 7 days after investigational product administration.\n* Is allergic to the investigational product or any of its constituents."}, 'identificationModule': {'nctId': 'NCT01886820', 'briefTitle': 'A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral Beta-Amyloid When Compared With Postmortem Histopathology', 'organization': {'class': 'INDUSTRY', 'fullName': 'Navidea Biopharmaceuticals'}, 'officialTitle': 'A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral Beta-Amyloid When Compared With Postmortem Histopathology', 'orgStudyIdInfo': {'id': 'NAV4-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[18F]NAV4694', 'description': 'Intravenous \\[18F\\]NAV4694 radioactive dose 8.1 mCi(300 MBq) given once', 'interventionNames': ['Drug: [18F]NAV4694']}], 'interventions': [{'name': '[18F]NAV4694', 'type': 'DRUG', 'armGroupLabels': ['[18F]NAV4694']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Sun Health Research Institute', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Neuropsychiatric Research Center of Southwest Florida', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Mount Sinai Medical Center of Florida', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '33166', 'city': 'Miami Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Galiz Research', 'geoPoint': {'lat': 25.82232, 'lon': -80.2895}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Compass Research', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Physicians Care Clinical Research', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62702', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Southern Illinois University School of Medicine', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '71103', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Biomedical Research Foundation', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '89113', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Las Vegas Radiology', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein College of Medicine', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27559', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Health-Gerontology', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45459', 'city': 'Centerville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Valley Medical Center', 'geoPoint': {'lat': 39.62839, 'lon': -84.15938}}], 'overallOfficials': [{'name': 'Cornelia Reininger, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Navidea Biopharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Navidea Biopharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}