Precision Medical Diagnosis for Parkinson's Disease - The Quantitative Analysis System for PET/MRI Images in Patients

NCT03909828 | Unknown

• 1 other identifier: 2018-10-001B
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

In nuclear medicine PET examinations, labeled radiopharmaceuticals are possible to enter the putamen and caudate nucleus regions of the striatum in the brain by intravenous injection. The severity of Parkinson's disease is assessed and diagnosed by quantitative analysis of the defect in the image of the radiopharmaceuticals. Clinical studies often use manual selection of regions of interest (ROIs) for quantitative analysis. However, this method causes human error and low reproducibility due to subjective factors, and also considerable time consuming. Therefore, in order to solve the above problems, this research project plans to build an automated quantitative analysis system for PET/MRI images. The quantitative analysis of the PET images is performed automatically by using the putamen and caudate ROI segmented by the MRI images. This automated quantitative analysis system is expected to improve the time-consuming, low reproducibility, and subjectivity problems of traditional manual ROI selection method, and provide a useful tool for the diagnosis of early PD. In the first year, this sub-project is expected to perform MRI T1 and 18F-FDOPA PET scanning of before and after acupuncture-treated PD patients provided by sub-project 3. In the second year, the correlation analysis will be made with the results of tremor test provided by sub-project 1 and that of the 99mTc-TRODAT SPECT image quantification provided by sub-project 4.

Conditions

Parkinson Disease; PET; MRI

Outcome Measures

Primary Outcomes (1)

• The comparison of the change of Standard Uptake Ration (SUR)

  This study will collect images from a total of 100 PD patients (20 patients in the first year and 80 patients in the second year). Patients will perform MRI T1 and 18F-FDOPA PET scanning of before and after acupuncture-treated PD patients in VGHTPE PET/MRI scanner. Every patient will be administered 185 MBq (5 mCi) of 18F-FDOPA by IV injection. The MRI image is used to extract the target and background ROIs (region of interests), and is coregistered to the PET image. The ROIs generated by MRI image will be applied to its corresponding PET image. Then, specific uptake ratio (SUR) will be calculated for each patient. The calculation of SUR is the difference between the average image pixel value of the target ROI (left and right striatum) and the average image pixel value of the background ROI (occipital lobe) divided by the average value of the background ROI.The unit of pixel is mm and the unit of SUR measurement is percentage (%).

  2 Months

Secondary Outcomes (5)

• The comparison of the change of asymmetry index (ASI)

  2 Months

• Unified Parkinson's Disease Rating Scale

  2 Months

• Micro Vibration Scan

  2 Months

• Constitution in Chinese Medicine Questionnaire (CCMQ)

  2 Months

• Sphygmograph

  2 Months

Other Outcomes (1)

• statistical method-T test

  1 year

Study Arms (1)

Parkinson's disease patients

patients with Idiopathic Parkinsonism

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population consist of the participants who fulfill the inclusion criteria in eligibility criteria.

You may qualify if:

• Diagnosed as Idiopathic Parkinsonism by Neurologist
• Have taken first line drugs more than three months
• Did not take any acupuncture or rehabilitation
• Voluntary

You may not qualify if:

• Taking anticancer drug now or diagnosed as depression, psychosis or other mental illnesses
• Medical history of stroke or dementia
• Taking anticoagulant now or having coagulation disorders
• Scalp infection
• Pregnant women
• Patient with irregular heartbeat, implanted artificial cardiac pacemaker or implanted cardioverter-defibrillator
• Belonephobia

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: April 10, 2019
• Study Start: April 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 10, 2019

Record last verified: 2019-04