Clinical trial NCT04334902: Evaluation of Clinical Decision Support System-mPDia for Neurodegenerative Parkinsonism Using MRI Images
Official title: An Open Label, Multicenter, Retrospective, Pivotal Trial to Evaluate the Efficacy of Clinical Decision Support System-mPDia for Neurodegenerative Parkinsonism Using MRI Images
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diagnoses Disease
Keywords: Neurodegenerative Parkinsonism
Lead sponsor: Heuron Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-06
Enrollment: 221
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: (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)

Brief summary: 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.


Eligibility criteria: Inclusion Criteria(Normal cohort):

* Adults over 19 years old
* 3T nigrosome 1 MRI acquired
* 18F FP-CIT PET/CT are confirmed to be normal
* The person who visits parkinsonism symptoms but is not or is normal for neurodegenerative parkinsonism

Inclusion Criteria(Abnormal cohort):

* Adults over 19 years old
* 3T nigrosome 1 MRI acquired
* 18F FP-CIT PET/CT are confirmed to be abnormal
* The person who visits parkinsonism symptoms and has been diagnosed with neurodegenerative parkinsonism

Exclusion Criteria:

* Patients with other brain diseases except parkinsonism
* Who have anatomical abnormality in MRIs etc.
* Who have other causes of tremor(e.g., thyroid disease)
* Patients with lesion in basal ganglia(e.g., vascular parkinsonism, hydrocephalus and Wilson's disease)

Primary outcomes:
measure: Sensitivity and specificity of mPDia
timeFrame: Within 4 weeks after collecting data
Secondary outcomes:
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Cha Medical Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Catholic University of Korea, Seoul ST. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: KyungHee University Medical Center
Study officials:
affiliation: Gachon University Gil Medical Center
name: YoungHee Sung, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: