Prospective Study for Neuromelanin Image Analysis

July 24, 2025 updated by: Heuron Inc.

Prospective Data Collect Study for Development of Neurimelanin Image Analysis System

In order to develop an image analysis system that automatically detects and quantifies neuromelanin, this study aims to construct a database of a wide sample by collecting brain MRI neuromelanin images prospectively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Nowon-gu
      • Seoul, Nowon-gu, Korea, Republic of, 01757
        • Inje University Sanggye Paik Hospital
    • Seodaemun gu
      • Seoul, Seodaemun gu, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
    • Yongin-si
      • Gyeonggi-do, Yongin-si, Korea, Republic of, 16995
        • Yong-in Severance Hospital, Yonsei University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Parkinsin group

Inclusion Criteria:

  • Adults over 19 years old
  • Those who have clinically shown Parkinson's symptoms such as tremor, Rigidity, Bradykinesa and gait disturbance and are scheduled to take MRI scans
  • Dopamine transporter imaging shows a significant decrease in visual dopamine intake
  • A person who can read and understand the description and informed consent form
  • Upon hearing and fully understanding the detailed explanation of this clinical trial, a person who has voluntarily decided to participate and agreed in writing to comply with the precautions

Exclusion Criteria:

  • Patient with a history of claustrophobia and mental illness;
  • Patient with metallic substances in the body
  • Any female subject who is likely to be pregnant who does not agree to contraception in a medically permitted manner during this clinical trial period
  • Pregnant or lactating women
  • Other cases where the investigator judged that it is difficult to participate in the study;

Healthy volunteer group

Inclusion Criteria:

  • Adults over 19 years old
  • A person who has no family history or diagnostic history of movement disorders;
  • A person with a score of 8 or higher on the CCSIT(cross cultural smell identification test)
  • A person with a score of 27 or higher on the MMSE Test
  • No Parkinson's symptoms on a neurological examination
  • Upon hearing and fully understanding the detailed explanation of this clinical trial, a person who has voluntarily decided to participate and agreed in writing to comply with the precautions

Exclusion Criteria:

  • Patient with a history of central nervous system disease or cognitive disorder
  • Patient with a history of claustrophobia and mental illness;
  • Patient with metallic substances in the body
  • Any female subject who is likely to be pregnant who does not agree to contraception in a medically permitted manner during this clinical trial period
  • Pregnant or lactating women
  • Other cases where the investigator judged that it is difficult to participate in the study;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient group
Patient with parkinson disease
Device: MRI Imaging
Neuromelanin sequence imaging
Experimental: Healthy volunteer group
Healthy volunteer
Device: MRI Imaging
Neuromelanin sequence imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in Neuromelanin Volume by Age
Time Frame: Within 1 weeks after enrollment
Descriptive Statistics for Neuromelanin Volume Measured by MRI Image by Age
Within 1 weeks after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in Neuromelanin Volume by group
Time Frame: Within 1 weeks after enrollment
Descriptive Statistics for Neuromelanin Volume Measured by MRI Image by group
Within 1 weeks after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heuron Inc.

Investigators

  • Principal Investigator: Phil Hyu Lee, M.D.pH.D, Severance Hospital, Yonsei University Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2022

Primary Completion (Actual)

July 2, 2024

Study Completion (Actual)

July 2, 2024

Study Registration Dates

First Submitted

August 22, 2022

First Submitted That Met QC Criteria

August 22, 2022

First Posted (Actual)

August 24, 2022

Study Record Updates

Last Update Posted (Actual)

July 28, 2025

Last Update Submitted That Met QC Criteria

July 24, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • qMT-PD-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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