Evaluation of Clinical Decision Support System-mPDia for Neurodegenerative Parkinsonism Using MRI Images

Diagnoses Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04334902
• Other study ID #: HR-MPD-01
• Status: Completed
• Start date: March 13, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: November 2020
• Source: Heuron Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: October 30, 2020
• Est. primary completion date: June 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diagnoses Disease
• Parkinsonian Disorders

Intervention

Device:
• mPDia
Clinical decision support system for diagnosing neurodegenerative parkinsonism

Locations

Country	Name	City	State
Korea, Republic of	Cha Medical Center	Gyeonggi-do
Korea, Republic of	Hallym University Dongtan Sacred Heart Hospital	Gyeonggi-do
Korea, Republic of	Hallym University Sacred Heart Hospital	Gyeonggi-do
Korea, Republic of	Korea University Ansan Hospital	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Catholic University of Korea, Seoul ST. Mary's Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	KyungHee University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Heuron Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of mPDia	Sensitivity and specificity of mPDia in diagnosis of neurodegenerative parkinsonism based on golden standards	Within 4 weeks after collecting data