Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT05513794
Status:
COMPLETED
Last Update Posted:
2025-07-28
First Post:
2022-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study for Neuromelanin Image Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'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': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2022-08-22', 'studyFirstSubmitQcDate': '2022-08-22', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in Neuromelanin Volume by Age', 'timeFrame': 'Within 1 weeks after enrollment', 'description': 'Descriptive Statistics for Neuromelanin Volume Measured by MRI Image by Age'}], 'secondaryOutcomes': [{'measure': 'Differences in Neuromelanin Volume by group', 'timeFrame': 'Within 1 weeks after enrollment', 'description': 'Descriptive Statistics for Neuromelanin Volume Measured by MRI Image by group'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'In order to develop an image analysis system that automatically detects and quantifies neuromelanin, this study aims to construct a database of a wide sample by collecting brain MRI neuromelanin images prospectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Parkinsin group\n\nInclusion Criteria:\n\n* Adults over 19 years old\n* Those who have clinically shown Parkinson's symptoms such as tremor, Rigidity, Bradykinesa and gait disturbance and are scheduled to take MRI scans\n* Dopamine transporter imaging shows a significant decrease in visual dopamine intake\n* A person who can read and understand the description and informed consent form\n* Upon hearing and fully understanding the detailed explanation of this clinical trial, a person who has voluntarily decided to participate and agreed in writing to comply with the precautions\n\nExclusion Criteria:\n\n* Patient with a history of claustrophobia and mental illness;\n* Patient with metallic substances in the body\n* Any female subject who is likely to be pregnant who does not agree to contraception in a medically permitted manner during this clinical trial period\n* Pregnant or lactating women\n* Other cases where the investigator judged that it is difficult to participate in the study;\n\nHealthy volunteer group\n\nInclusion Criteria:\n\n* Adults over 19 years old\n* A person who has no family history or diagnostic history of movement disorders;\n* A person with a score of 8 or higher on the CCSIT(cross cultural smell identification test)\n* A person with a score of 27 or higher on the MMSE Test\n* No Parkinson's symptoms on a neurological examination\n* Upon hearing and fully understanding the detailed explanation of this clinical trial, a person who has voluntarily decided to participate and agreed in writing to comply with the precautions\n\nExclusion Criteria:\n\n* Patient with a history of central nervous system disease or cognitive disorder\n* Patient with a history of claustrophobia and mental illness;\n* Patient with metallic substances in the body\n* Any female subject who is likely to be pregnant who does not agree to contraception in a medically permitted manner during this clinical trial period\n* Pregnant or lactating women\n* Other cases where the investigator judged that it is difficult to participate in the study;"}, 'identificationModule': {'nctId': 'NCT05513794', 'briefTitle': 'Prospective Study for Neuromelanin Image Analysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Heuron Inc.'}, 'officialTitle': 'Prospective Data Collect Study for Development of Neurimelanin Image Analysis System', 'orgStudyIdInfo': {'id': 'qMT-PD-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient group', 'description': 'Patient with parkinson disease', 'interventionNames': ['Device: MRI Imaging']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy volunteer group', 'description': 'Healthy volunteer', 'interventionNames': ['Device: MRI Imaging']}], 'interventions': [{'name': 'MRI Imaging', 'type': 'DEVICE', 'description': 'Neuromelanin sequence imaging', 'armGroupLabels': ['Healthy volunteer group', 'Patient group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01757', 'city': 'Seoul', 'state': 'nowon-gu', 'country': 'South Korea', 'facility': 'Inje University Sanggye Paik Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'state': 'Seodaemun gu', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '16995', 'city': 'Gyeonggi-do', 'state': 'yongin-si', 'country': 'South Korea', 'facility': 'Yong-in Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}], 'overallOfficials': [{'name': 'Phil Hyu Lee, M.D.pH.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital, Yonsei University Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heuron Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}