Ignite Creation Date:
2025-12-25 @ 3:41 AM
Ignite Modification Date:
2025-12-26 @ 2:27 AM
Study NCT ID:
NCT04334902
Status:
COMPLETED
Last Update Posted:
2025-10-29
First Post:
2020-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Clinical Decision Support System-mPDia for Neurodegenerative Parkinsonism Using MRI Images
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yoomi_kim@iheuron.com', 'phone': '01035173212', 'title': 'Yoomi Kim_Clinical Research Team Leader', 'organization': 'Heuron'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Not Applilcable(Retrospective Study)', 'description': 'All-Cause Mortality, Serious Adverse Events, and Other (Non-Serious) Adverse Events were not monitored or assessed in this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Abnormal', 'description': 'The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Normal', 'description': 'The person who visits parkinsonism symptoms but is not or is normal for neurodegenerative parkinsonism', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sensitivity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abnormal', 'description': 'The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism'}, {'id': 'OG001', 'title': 'Normal', 'description': 'The person who presented with parkinsonism symptoms but were determined not to have neurodegenerative parkinsonism.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.30', 'groupId': 'OG000', 'lowerLimit': '90.69', 'upperLimit': '97.92'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Visit 2 (within 4 weeks after Visit 1)', 'description': 'Sensitivity of mPDia in diagnosing neurodegenerative parkinsonism, based on comparison with the golden standard (final clinical diagnosis determined by specialist groups).\n\nSensitivity was calculated as TP/(TP+FN) Sensitivity: 100 x True positive(TP)/ \\[True positive(TP) + False negative(FN)\\] (%)', 'unitOfMeasure': 'percentage', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Sensitivity is calculated only in the Abnormal group (patients diagnosed with neurodegenerative parkinsonism).\n\nThe Normal group is not applicable for this analysis, therefore the number of participants analyzed is recorded as 0.'}, {'type': 'PRIMARY', 'title': 'Specificity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abnormal', 'description': 'The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism'}, {'id': 'OG001', 'title': 'Normal', 'description': 'The person who visits parkinsonism symptoms but is not or is normal for neurodegenerative parkinsonism'}], 'classes': [{'categories': [{'measurements': [{'value': '91.67', 'groupId': 'OG001', 'lowerLimit': '84.67', 'upperLimit': '98.66'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Visit 2 (within 4 weeks after Visit 1)', 'description': 'Specificity of mPDia in diagnosing neurodegenerative parkinsonism, based on comparison with the golden standard (final clinical diagnosis determined by specialist groups).\n\nSpecificity was calculated as True Negative / (True Negative + False Positive) Specificity: 100 x True negative(TN)/\\[False positive(FP) + True negative(TN)\\] (%)', 'unitOfMeasure': 'percentage', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Specificity is calculated only in the Normal group (participants without neurodegenerative parkinsonism).\n\nThe Abnormal group is not applicable for this analysis, therefore the number of participants analyzed is recorded as 0.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Abnormal', 'description': 'The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism'}, {'id': 'FG001', 'title': 'Normal', 'description': 'The person who presented with parkinsonism symptoms but were determined not to have neurodegenerative parkinsonism.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The data will be collected retrospectively from person whose past 3T nigrosome 1 MRI image, 18F FP-CIT PET/CT image, image interpretation, and neurologic exam results are confirmed by medical records, and those whose diagnosis as neurodegenerative Parkinsonism is confirmed. Data collecting must be executed following therandom collection. Only the verified researcher who is registered in this study will have access to medical records.', 'preAssignmentDetails': 'At each Institution, participants who met all inclusion and exclusion criteria for this study were randomly selected up to the target number of participants. Based on the medical record diagnosis of neurodegenerative parkinsonism, participants were classified into the normal group or the patient group. The data from the randomly selected participants were used for diagnostic evaluation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Abnormal', 'description': 'The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism'}, {'id': 'BG001', 'title': 'Normal', 'description': 'The person who visits parkinsonism symptoms but is not or is normal for neurodegenerative parkinsonism'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'For the demographic information checked at visit 1, in the case of age, descriptive statistics (number, mean, standard deviation, median, minimum, maximum) were presented as continuous variables, and in the case of sex, frequency and percentage (%) were presented as categorical variables', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'Since this clinical trial is not a parallel design comparing two groups, comparative analysis of basic data and test results between the normal group and the patient group was not conducted.'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '65.85', 'spread': '10.50', 'groupId': 'BG000'}, {'value': '68.35', 'spread': '8.04', 'groupId': 'BG001'}, {'value': '66.54', 'spread': '9.93', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The mean age of the enrolled cases was 66.54±9.93 years, and subjects from 37 to 90 years old participated, and the mean age of the patient group was 65.85±10.50 years, and the mean age of the normal group was 68.35±8.04 years.', 'unitOfMeasure': 'year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Of the 221 cases(patient group 159 cases, normal group 62 cases) enrolled in this clinical trial, 218 cases(patient group 158 cases-5056 images, normal group 60 cases-1920 images) who completed the trial according to the clinical trial protocol were used as data for efficacy assessment, excluding 3 people (1.36%) dropped out. In the case of demographic information and basic data, the analysis was conducted with the corresponding data.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-06', 'size': 256558, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-24T23:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 221}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2020-04-02', 'resultsFirstSubmitDate': '2025-07-28', 'studyFirstSubmitQcDate': '2020-04-02', 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-29', 'studyFirstPostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism', 'timeFrame': 'At Visit 2 (within 4 weeks after Visit 1)', 'description': 'Sensitivity of mPDia in diagnosing neurodegenerative parkinsonism, based on comparison with the golden standard (final clinical diagnosis determined by specialist groups).\n\nSensitivity was calculated as TP/(TP+FN) Sensitivity: 100 x True positive(TP)/ \\[True positive(TP) + False negative(FN)\\] (%)'}, {'measure': 'Specificity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism', 'timeFrame': 'At Visit 2 (within 4 weeks after Visit 1)', 'description': 'Specificity of mPDia in diagnosing neurodegenerative parkinsonism, based on comparison with the golden standard (final clinical diagnosis determined by specialist groups).\n\nSpecificity was calculated as True Negative / (True Negative + False Positive) Specificity: 100 x True negative(TN)/\\[False positive(FP) + True negative(TN)\\] (%)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neurodegenerative Parkinsonism'], 'conditions': ['Diagnoses Disease']}, 'descriptionModule': {'briefSummary': 'mPDia is a software that has been pre-learned based on a neurodegenerative parkinsonism diagnosis model using Nigrosome 1 MRI images, and clinical decision support system for diagnosing neurodegenerative parkinsonism by automatically analyzing Nigrosome 1 MRI images by assisting the medical team.\n\nThe specific aims of this study are to evaluate efficacy of mPDia for neurodegenerative Parkinsonism compared to the sensitivity and specificity levels of 18F FP-CIT PET/CT which is currently used to diagnose neurodegenerative parkinsonism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '(1) Adults over 19 years old (2) 3T nigrosome 1 MRI acquired (3) 18F FP-CIT PET/CT are confirmed to be normal(normal cohort) or abnormal(abnormal cohort)', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria(Normal cohort):\n\n* Adults over 19 years old\n* 3T nigrosome 1 MRI acquired\n* 18F FP-CIT PET/CT are confirmed to be normal\n* The person who visits parkinsonism symptoms but is not or is normal for neurodegenerative parkinsonism\n\nInclusion Criteria(Abnormal cohort):\n\n* Adults over 19 years old\n* 3T nigrosome 1 MRI acquired\n* 18F FP-CIT PET/CT are confirmed to be abnormal\n* The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism\n\nExclusion Criteria:\n\n* Patients with other brain diseases except parkinsonism\n* Who have anatomical abnormality in MRIs etc.\n* Who have other causes of tremor(e.g., thyroid disease)\n* Patients with lesion in basal ganglia(e.g., vascular parkinsonism, hydrocephalus and Wilson's disease)"}, 'identificationModule': {'nctId': 'NCT04334902', 'briefTitle': 'Evaluation of Clinical Decision Support System-mPDia for Neurodegenerative Parkinsonism Using MRI Images', 'organization': {'class': 'INDUSTRY', 'fullName': 'Heuron Inc.'}, 'officialTitle': 'An Open Label, Multicenter, Retrospective, Pivotal Trial to Evaluate the Efficacy of Clinical Decision Support System-mPDia for Neurodegenerative Parkinsonism Using MRI Images', 'orgStudyIdInfo': {'id': 'HR-MPD-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Abnormal', 'description': 'The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism', 'interventionNames': ['Device: mPDia']}, {'label': 'Normal', 'description': 'The person who visits parkinsonism symptoms but is not or is normal for neurodegenerative parkinsonism', 'interventionNames': ['Device: mPDia']}], 'interventions': [{'name': 'mPDia', 'type': 'DEVICE', 'description': 'Clinical decision support system for diagnosing neurodegenerative parkinsonism', 'armGroupLabels': ['Abnormal', 'Normal']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Cha Medical Center', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Hallym University Dongtan Sacred Heart Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "Catholic University of Korea, Seoul ST. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'KyungHee University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'YoungHee Sung, M.D, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gachon University Gil Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heuron Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}