Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-12 @ 2:43 AM
Study NCT ID:
NCT01838018
Status:
COMPLETED
Last Update Posted:
2018-05-29
First Post:
2013-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Perfusion in Pantothenate Kinase-associated Neurodegeneration (PKAN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006211', 'term': 'Pantothenate Kinase-Associated Neurodegeneration'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019150', 'term': 'Neuroaxonal Dystrophies'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-24', 'studyFirstSubmitDate': '2013-04-18', 'studyFirstSubmitQcDate': '2013-04-22', 'lastUpdatePostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ASL-derived cerebral blood flow(CBF)', 'timeFrame': 'Single MRI', 'description': 'The unit of analyses will be the subject and the primary comparison will be the globus pallidus CBF between PKAN and healthy controls.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PKAN', 'brain iron', 'NBIA', 'neurodegeneration with brain iron accumulation', 'Hallervorden Spatz Syndrome'], 'conditions': ['Pantothenate Kinase-associated Neurodegeneration (PKAN)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ohsu.edu/xd/education/schools/school-of-medicine/departments/basic-science-departments/molecular-and-medical-genetics/people/primary-faculty/susan-hayflick.cfm', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn whether blood flow in the brain is normal in people with pantothenate kinase-associated neurodegeneration (PKAN). Specifically, preliminary data suggest a region of the brain called the globus pallidus (GP), a key region affected by PKAN, may have reduced blood flow. Standard MRI and perfusion scanning techniques will be used to learn about cerebral blood flow in the globus pallidus and compare it to blood flow in other brain regions as well as to healthy controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The PKAN group consists of individuals in the United States diagnosed with PKAN.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of PKAN confirmed by MRI and gene testing\n* able to undergo MRI for approximately 1 hour without sedation\n\nExclusion Criteria:\n\n* deep brain stimulators or other conditions that warrant avoidance of a strong magnetic field\n* previous reaction to gadolinium (Gd) contrast agent\n* acute or chronic kidney dysfunction\n* pregnant and/or nursing at time of study'}, 'identificationModule': {'nctId': 'NCT01838018', 'briefTitle': 'Brain Perfusion in Pantothenate Kinase-associated Neurodegeneration (PKAN)', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Brain Perfusion in Pantothenate Kinase-Associated Neurodegeneration (PKAN)', 'orgStudyIdInfo': {'id': '8777'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PKAN', 'description': 'This group consists of individuals diagnosed with PKAN using a combination of MRI and PANK2 gene sequencing.'}, {'label': 'Healthy volunteers', 'description': 'This is a control group of healthy volunteers, matched with the PKAN group for age and sex.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Susan J Hayflick, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Susan J. Hayflick', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oregon Health and Science University', 'class': 'OTHER'}, {'name': 'Oregon Clinical and Translational Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor & Chair, Molecular & Medical Genetics', 'investigatorFullName': 'Susan J. Hayflick', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}