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Parkinson DiseaseNCT03909828

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

An observational study of Parkinson Disease and PET, run by Taipei Veterans General Hospital, Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Parkinson Disease, PET, MRI
How many people
100 participants
Where
No sites listed yet
Study dates
Apr 2019to 31 Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

About this study

Official title: Precision Medical Diagnosis and Acupuncture Treatment for Parkinson's Disease - The Quantitative Analysis System for PET/MRI Images in Patients

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.

Read the detailed description

Parkinson's disease (PD) is a neurodegenerative disease whose pathogenic mechanism is the degeneration of substantia nigra of the midbrain, causing the degeneration of dopaminergic neurons in the putamen and caudate nucleus of the striatum, and the dopamine content in the synapses decreases and gradually loses the ability to act. Most of the clinical symptoms are motor function defects. The most obvious symptoms are tremor, limb stiffness, motor dysfunction and gait abnormality, and cognitive and behavioral problems may occur. 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. In this study, 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. After calculated each patients' standard uptake ration, Asymmetry index (ASI) can be calculated based on the absolute difference of SUR value of both sides (left and right) of striatum, divided by average SUR value of both sides of striatum. 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.

Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03909828
Study groupRoleWhat they receive
Parkinson's disease patientspatients with Idiopathic Parkinsonism

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 (%).

    Measured: 2 Months

Secondary outcomes (5)

  1. The comparison of the change of asymmetry index (ASI)

    After calculated each patients' standard uptake ration, Asymmetry index (ASI) can be calculated based on the absolute difference of SUR value of both sides (left and right) of striatum, divided by average SUR value of both sides of striatum. The unit of ASI measurement is percentage (%).

    Measured: 2 Months

  2. Unified Parkinson's Disease Rating Scale

    A comprehensive assessment of both motor and non-motor symptoms associated with Parkinson's. The Unified Parkinson's Disease Rating Scale is made up of 42 items. These items are divided into six sections which are separately "evaluation of mentation, behavior, and mood", "self-evaluation of the activities of daily life", "clinician-scored monitored motor evaluation", "complications of therapy", "Hoehn and Yahr staging of severity of Parkinson's disease" and "Schwab and England ADL scale".The evaluation score for the first item to the 39th item is 0 to 4 points. The evaluation score for the 40th to the 42th item is 0 to 1 points. The higher score meand the worse condition. The sum of all the items'score is the score of the scale. Highr Rating Scales'scores indicate severe symptoms.

    Measured: 2 Months

  3. Micro Vibration Scan

    1. Discover early symptom before the onset.
    2. Recognize PD tremor pattern within 1 minute.
    3. Non-invasive, Non-radiation, and Low-cost medical device for daily tracking and treatment evaluation.
    4. Discover early symptom before the onset. 2. Recognize PD tremor pattern within 1 minute. 3. Non-invasive, Non-radiation, and Low-cost medical device for daily tracking and treatment evaluation.
    5. Discover early symptom before the onset.
    6. Recognize PD tremor pattern within 1 minute.
    7. Non-invasive, Non-radiation, and Low-cost medical device for daily tracking and treatment evaluation.

    Measured: 2 Months

  4. Constitution in Chinese Medicine Questionnaire (CCMQ)

    Sixty items were applied to measure the nine constitutions: Neutral (a normal constitution), Qi-deficiency constitution, Yang-deficiency constitution, Yin-deficiency constitution, Phlegm-dampness constitution, Damp-heat constitution, Stagnant-blood constitution, Stagnant-Qi constitution, and Inherited-special constitution.

    Measured: 2 Months

  5. Sphygmograph

    Diagnoses patient's pulse change

    Measured: 2 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2019
  2. Study startApr 2019 (estimated)
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03909828
Sponsor's protocol ID
2018-10-001B
Status last verified
Apr 2019
First submitted
22 Jan 2019
Last updated
10 Apr 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease and PET, run by Taipei Veterans General Hospital, Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The comparison of the change of Standard Uptake Ration (SUR) (time frame: 2 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03909828.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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