Clinical Trials Directory

Trials / Completed

CompletedNCT04334902

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

An Open Label, Multicenter, Retrospective, Pivotal Trial to Evaluate the Efficacy of Clinical Decision Support System-mPDia for Neurodegenerative Parkinsonism Using MRI Images

Status
Completed
Phase
Study type
Observational
Enrollment
221 (actual)
Sponsor
Heuron Inc. · Industry
Sex
All
Age
19 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEmPDiaClinical decision support system for diagnosing neurodegenerative parkinsonism

Timeline

Start date
2020-03-13
Primary completion
2020-06-24
Completion
2020-10-30
First posted
2020-04-06
Last updated
2025-10-29
Results posted
2025-10-29

Locations

10 sites across 1 country: South Korea

Source: ClinicalTrials.gov record NCT04334902. Inclusion in this directory is not an endorsement.