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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.
The 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abnormal | The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism |
| |
| Normal | The person who visits parkinsonism symptoms but is not or is normal for neurodegenerative parkinsonism |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mPDia | Device | Clinical decision support system for diagnosing neurodegenerative parkinsonism |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism | Sensitivity of mPDia in diagnosing neurodegenerative parkinsonism, based on comparison with the golden standard (final clinical diagnosis determined by specialist groups). Sensitivity was calculated as TP/(TP+FN) Sensitivity: 100 x True positive(TP)/ [True positive(TP) + False negative(FN)] (%) | At Visit 2 (within 4 weeks after Visit 1) |
| Specificity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism | Specificity of mPDia in diagnosing neurodegenerative parkinsonism, based on comparison with the golden standard (final clinical diagnosis determined by specialist groups). Specificity was calculated as True Negative / (True Negative + False Positive) Specificity: 100 x True negative(TN)/[False positive(FP) + True negative(TN)] (%) | At Visit 2 (within 4 weeks after Visit 1) |
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Inclusion Criteria(Normal cohort):
Inclusion Criteria(Abnormal cohort):
Exclusion Criteria:
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(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)
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| Name | Affiliation | Role |
|---|---|---|
| YoungHee Sung, M.D, Ph.D | Gachon University Gil Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cha Medical Center | Gyeonggi-do | South Korea | ||||
| Hallym University Dongtan Sacred Heart Hospital |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Abnormal | The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism |
| FG001 | Normal | The person who presented with parkinsonism symptoms but were determined not to have neurodegenerative parkinsonism. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Abnormal | The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism |
| BG001 | Normal | The person who visits parkinsonism symptoms but is not or is normal for neurodegenerative parkinsonism |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Sex: Female, Male | 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 |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism | Sensitivity of mPDia in diagnosing neurodegenerative parkinsonism, based on comparison with the golden standard (final clinical diagnosis determined by specialist groups). Sensitivity was calculated as TP/(TP+FN) Sensitivity: 100 x True positive(TP)/ [True positive(TP) + False negative(FN)] (%) | Sensitivity is calculated only in the Abnormal group (patients diagnosed with neurodegenerative parkinsonism). The Normal group is not applicable for this analysis, therefore the number of participants analyzed is recorded as 0. | Posted | Number | 90% Confidence Interval | percentage | At Visit 2 (within 4 weeks after Visit 1) |
|
Not Applilcable(Retrospective Study)
All-Cause Mortality, Serious Adverse Events, and Other (Non-Serious) Adverse Events were not monitored or assessed in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Abnormal | The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yoomi Kim_Clinical Research Team Leader | Heuron | 01035173212 | yoomi_kim@iheuron.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 6, 2020 | Jul 24, 2025 | Prot_SAP_000.pdf |
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| Gyeonggi-do |
| South Korea |
| Hallym University Sacred Heart Hospital | Gyeonggi-do | South Korea |
| Korea University Ansan Hospital | Gyeonggi-do | South Korea |
| Gachon University Gil Medical Center | Incheon | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul | South Korea |
| Gangnam Severance Hospital | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| KyungHee University Medical Center | Seoul | South Korea |
| BG002 | Total | Total of all reporting groups |
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. |
| Count of Participants |
| Participants |
| No |
|
| Age, Continuous | 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. | Mean | Standard Deviation | year |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 |
| Normal |
The person who presented with parkinsonism symptoms but were determined not to have neurodegenerative parkinsonism. |
|
|
| Primary | Specificity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism | Specificity of mPDia in diagnosing neurodegenerative parkinsonism, based on comparison with the golden standard (final clinical diagnosis determined by specialist groups). Specificity was calculated as True Negative / (True Negative + False Positive) Specificity: 100 x True negative(TN)/[False positive(FP) + True negative(TN)] (%) | Specificity is calculated only in the Normal group (participants without neurodegenerative parkinsonism). The Abnormal group is not applicable for this analysis, therefore the number of participants analyzed is recorded as 0. | Posted | Number | 90% Confidence Interval | percentage | At Visit 2 (within 4 weeks after Visit 1) |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Normal | The person who visits parkinsonism symptoms but is not or is normal for neurodegenerative parkinsonism | 0 | 0 | 0 | 0 | 0 | 0 |
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