Idiopathic Parkinson's DiseaseNCT02801110
PET/MR Imaging in Patients With Short and Long Standing Parkinson's Disease
An observational study of Idiopathic Parkinson's Disease, run by david groshar.
Trial summary
Parkinson's disease (PD) is a chronic, progressive, neurodegenerative disease that affects 1% of the population older than 60 years. The disease presents as a movement disorder manifesting mainly with resting tremor, bradykinesia, cogwheel rigidity and postural instability along with cognitive and behavioral… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Idiopathic Parkinson's Disease
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2018
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with IPD suffering from asymmetrical motor signs.
Who may be able to join
- Age above 30 below 80 years of age.
- A clinical diagnosis of idiopathic PD.
- Patients with asymmetric presentation of PD (by history/medical documentation).
- Patients with persistent motor asymmetry (with side predominance respecting the side of symptom onset).
Who cannot join
- Patients with history of other brain disorder/pathology.
- Patients with atypical signs suggesting another neurodegenerative disorder, psychiatric disorders, signs of severe cognitive deterioration, severe cardiovascular comorbidity
- Patients treated with levodopa.
- Patients on medication known to interfere with the DAT or catechol O-methyltransferase inhibitors, or with dopamine receptor blocking / or catecholamine re-uptake blocking properties.
- Patients suffering from dystonia.
- Pregnancy/ Breastfeeding.
- Contraindication to MR imaging.
- Uncontrolled head/body movements.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of [18F] FDOPA PET/MR Imaging in Patients With Short and Long Standing Parkinson's Disease: Pilot Study
Parkinson's disease (PD) is a chronic, progressive, neurodegenerative disease that affects 1% of the population older than 60 years. The disease presents as a movement disorder manifesting mainly with resting tremor, bradykinesia, cogwheel rigidity and postural instability along with cognitive and behavioral disturbances and symptoms of other non-motor systems dysfunction. The pathophysiology of the motor dysfunction in PD is related to gradual loss of nigrostriatal dopaminergic neurons (originating from the substantia nigra (SN) compacta to the striatum) leading eventually to depletion of dopamine in the striatum.
Striatal fluorine-18 isotopologue for L-3,4-dihydroxyphenylalanine([18F] F-DOPA) uptake follows a typical spatiotemporal pattern along the course of disease starting with a decreased uptake in the dorso-caudal putamen (contralateral to the side of predominant motor involvement) that progress to the caudate nucleus.
Read more
The role of traditional magnetic resonance imaging (MRI) in the evaluation of PD is aimed mainly to differentiate idiopathic PD from secondary parkinsonism (e.g. vascular) and from other degenerative but atypical parkinsonian syndromes (e.g.Progressive supranuclear palsy ( PSP), Multiple system atrophy (MSA) etc.) that are associated with distinct structural features and therefore help establishing the diagnosis. However, new MR sequences such as diffuse tensor imaging (DTI) and susceptibility-weighted imaging (SWI) are now being investigated to evaluate the nigrostriatal dopaminergic neurons and iron accumulation in the SN, respectively.
Resting-state functional magnetic resonance imaging (fMRI) that depicts brain network organization has been shown to be altered in patients with PD. In this technique, temporally synchronous, spatially distributed, spontaneous low frequency blood-oxygen level-dependent signal fluctuations in task-free settings are further clustered into maps of functional large-scale neural networks. Lower network efficiency that worsens as disease progresses has been shown in patients with PD.
Recently, it has been shown that the integration of MRI and PET is technically feasible. The investigators believe that PET/MRI offers true multimodality imaging by combining anatomy, function and molecular processes that will allow more accurate identification of disease progression.
To the best of our knowledge, this will be the first study to evaluate idiopathic PD (IPD) with 18F FDOPA PET/MRI.
The aim of the study is to assess the feasibility of the modality and to evaluate both visually and quantitatively the association between the dopamine metabolism measured in the striatum by 18F-FDOPA PET with structural and functional MR findings in patients diagnosed with IPD with asymmetrical motor signs.
Read the detailed description
Study Objectives and Purpose:
- To assess the feasibility of 18F FDOPA PET/MR in the setting of IPD.
- To correlate and compare pattern of dynamic and/or static 18F-FDOPA uptake in the striatum with MR findings.
- To compare the different variables between the contra and ipsilateral hemispheric side of predominant motor involvement in patients with asymmetric motor disturbances.
Materials and Methods:
Study Design: This is a prospective, pilot, cohort
Study population:
Patients diagnosed with IPD suffering from asymmetrical motor signs.
Participant recruitment:
Eligible consecutive patients, satisfying the inclusion criteria, will be identified and recruited by neurological clinics.
Informed consent: Before enrollment, written informed consent will be obtained from each patient.
Participant Sampling: All patients fulfilling inclusion criteria and providing informed consent will be consecutively enrolled.
Imaging diagnostic PET/MR protocol All scans will be performed in the department of Nuclear Medicine at Tel-Aviv Assuta Medical Center using a PET/MR scanner (Biograph mMR, Siemens AG, Erlangen, Germany) in accordance with the manufacturer's guidelines.
Patients are required to fast at least 4 hours prior to arrival to the department. Upon arrival an intravenous catheter will be placed for radiopharmaceutical and gadolinium administration. Patients will receive an intravenous injection of 10 Millicurie (mCi) of 18F-FDOPA on the PET MR table and scanning will begin immediately. Dynamic PET parameters will be acquired along with the different MR sequences. MR of the brain will include the following sequences: T1, T2 and T2 fluid attenuated inversion recovery sequence (FLAIR), susceptibility-weighted sequences (SWI), blood-oxygenation level-dependent (BOLD) signals for resting-state functional imaging. In addition, perfusion of the brain will be evaluated with and without gadolinium.
For contrast-enhanced sequences the investigators use Dotarem (gadoteric acid)(0.2 ml/kg ,0.1 mmol/kg at 2ml/s, 20ml saline flush) The total scan time will be about 45 minutes.
Data collection:
For eligible patients, the following data will be recorded at baseline.
- Baseline parameters: date of birth, sex, age at diagnosis and (motor) symptoms onset.
- Detailed medical history.
- Physical examination.
- List of medications (and doses for anti PD and psychiatric medications)
- Hoehn and Yahr stage.
- Evaluation using the Movement Disorders Society - performed by neurologist.
MR findings:
- Abnormal structural findings of the brain.
- DTI measurements in the nigrostriatal dopaminergic neuron tracts.
- Iron overload in the SN.
- Comparison of resting-state brain networks in patients with asymmetrical motor signs with normal maps
PET findings:
- Visual assessment and quantitative measurements of static F-DOPA (e.g.,Standardized Uptake Values (SUV) SUVmax and SUVmean) will be performed in the putamen and caudate nucleus bilaterally.
- Measurements of dynamic F-DOPA parameters when available ( e.g., time to peak, peak value etc.) will be measured.
Statistics Patient characteristics will be summarized using descriptive statistics. Quantitative variables will be presented as mean and SD, qualitative variables will be presented as frequencies.
Pearson correlation coefficient will be used to measure the strength of the relationship between the PET and the MR parameters.
A t-test will be used to compare the mean values of the different parameters. Sample size: This is a pilot study for which a sample size of 40 patients is required.
- Conditions
- Idiopathic Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between SUV to DTI measurements
non interventional study.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- david groshar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, david groshar, Assuta Medical Center
- Investigators
- David Groshar, MD, Principal investigator, Head of nuclear medicine unit in Assuta Medical Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801110
- Sponsor's protocol ID
- 0015-16-ASMC
- Status last verified
- Jun 2016
- First submitted
- 13 Jun 2016
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of [18F] FDOPA PET/MR Imaging in Patients With Short and Long Standing Parkinson's Disease: Pilot Study
- ClinicalTrials.gov ID
- NCT02801110
- Acronym / sponsor ID
- 0015-16-ASMC
- Conditions
- Idiopathic Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- david grosharUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parkinson's disease (PD) is a chronic, progressive, neurodegenerative disease that affects 1% of the population older than 60 years. The disease presents as a movement disorder manifesting mainly with resting tremor, bradykinesia, cogwheel rigidity and postural instability along with cognitive and behavioral disturbances and symptoms of other non-motor systems dysfunction. The pathophysiology of the motor dysfunction in PD is related to gradual loss of nigrostriatal dopaminergic neurons (originating from the substantia nigra (SN) compacta to the striatum) leading eventually to depletion of dopamine in the striatum.
Striatal fluorine-18 isotopologue for L-3,4-dihydroxyphenylalanine([18F] F-DOPA) uptake follows a typical spatiotemporal pattern along the course of disease starting with a decreased uptake in the dorso-caudal putamen (contralateral to the side of predominant motor involvement) that progress to the caudate nucleus.
The role of traditional magnetic resonance imaging (MRI) in the evaluation of PD is aimed mainly to differentiate idiopathic PD from secondary parkinsonism (e.g. vascular) and from other degenerative but atypical parkinsonian syndromes (e.g.Progressive supranuclear palsy ( PSP), Multiple system atrophy (MSA) etc.) that are associated with distinct structural features and therefore help establishing the diagnosis. However, new MR sequences such as diffuse tensor imaging (DTI) and susceptibility-weighted imaging (SWI) are now being investigated to evaluate the nigrostriatal dopaminergic neurons and iron accumulation in the SN, respectively.
Resting-state functional magnetic resonance imaging (fMRI) that depicts brain network organization has been shown to be altered in patients with PD. In this technique, temporally synchronous, spatially distributed, spontaneous low frequency blood-oxygen level-dependent signal fluctuations in task-free settings are further clustered into maps of functional large-scale neural networks. Lower network efficiency that worsens as disease progresses has been shown in patients with PD.
Recently, it has been shown that the integration of MRI and PET is technically feasible. The investigators believe that PET/MRI offers true multimodality imaging by combining anatomy, function and molecular processes that will allow more accurate identification of disease progression.
To the best of our knowledge, this will be the first study to evaluate idiopathic PD (IPD) with 18F FDOPA PET/MRI.
The aim of the study is to assess the feasibility of the modality and to evaluate both visually and quantitatively the association between the dopamine metabolism measured in the striatum by 18F-FDOPA PET with structural and functional MR findings in patients diagnosed with IPD with asymmetrical motor signs.
Detailed description
Study Objectives and Purpose:
- To assess the feasibility of 18F FDOPA PET/MR in the setting of IPD.
- To correlate and compare pattern of dynamic and/or static 18F-FDOPA uptake in the striatum with MR findings.
- To compare the different variables between the contra and ipsilateral hemispheric side of predominant motor involvement in patients with asymmetric motor disturbances.
Materials and Methods:
Study Design: This is a prospective, pilot, cohort
Study population:
Patients diagnosed with IPD suffering from asymmetrical motor signs.
Participant recruitment:
Eligible consecutive patients, satisfying the inclusion criteria, will be identified and recruited by neurological clinics.
Informed consent: Before enrollment, written informed consent will be obtained from each patient.
Participant Sampling: All patients fulfilling inclusion criteria and providing informed consent will be consecutively enrolled.
Imaging diagnostic PET/MR protocol All scans will be performed in the department of Nuclear Medicine at Tel-Aviv Assuta Medical Center using a PET/MR scanner (Biograph mMR, Siemens AG, Erlangen, Germany) in accordance with the manufacturer's guidelines.
Patients are required to fast at least 4 hours prior to arrival to the department. Upon arrival an intravenous catheter will be placed for radiopharmaceutical and gadolinium administration. Patients will receive an intravenous injection of 10 Millicurie (mCi) of 18F-FDOPA on the PET MR table and scanning will begin immediately. Dynamic PET parameters will be acquired along with the different MR sequences. MR of the brain will include the following sequences: T1, T2 and T2 fluid attenuated inversion recovery sequence (FLAIR), susceptibility-weighted sequences (SWI), blood-oxygenation level-dependent (BOLD) signals for resting-state functional imaging. In addition, perfusion of the brain will be evaluated with and without gadolinium.
For contrast-enhanced sequences the investigators use Dotarem (gadoteric acid)(0.2 ml/kg ,0.1 mmol/kg at 2ml/s, 20ml saline flush) The total scan time will be about 45 minutes.
Data collection:
For eligible patients, the following data will be recorded at baseline.
- Baseline parameters: date of birth, sex, age at diagnosis and (motor) symptoms onset.
- Detailed medical history.
- Physical examination.
- List of medications (and doses for anti PD and psychiatric medications)
- Hoehn and Yahr stage.
- Evaluation using the Movement Disorders Society - performed by neurologist.
MR findings:
- Abnormal structural findings of the brain.
- DTI measurements in the nigrostriatal dopaminergic neuron tracts.
- Iron overload in the SN.
- Comparison of resting-state brain networks in patients with asymmetrical motor signs with normal maps
PET findings:
- Visual assessment and quantitative measurements of static F-DOPA (e.g.,Standardized Uptake Values (SUV) SUVmax and SUVmean) will be performed in the putamen and caudate nucleus bilaterally.
- Measurements of dynamic F-DOPA parameters when available ( e.g., time to peak, peak value etc.) will be measured.
Statistics Patient characteristics will be summarized using descriptive statistics. Quantitative variables will be presented as mean and SD, qualitative variables will be presented as frequencies.
Pearson correlation coefficient will be used to measure the strength of the relationship between the PET and the MR parameters.
A t-test will be used to compare the mean values of the different parameters. Sample size: This is a pilot study for which a sample size of 40 patients is required.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with IPD suffering from asymmetrical motor signs.
Key inclusion criteria (4 listed)
- Age above 30 below 80 years of age.
- A clinical diagnosis of idiopathic PD.
- Patients with asymmetric presentation of PD (by history/medical documentation).
- Patients with persistent motor asymmetry (with side predominance respecting the side of symptom onset).
Key exclusion criteria (8 listed)
- Patients with history of other brain disorder/pathology.
- Patients with atypical signs suggesting another neurodegenerative disorder, psychiatric disorders, signs of severe cognitive deterioration, severe cardiovascular comorbidity
- Patients treated with levodopa.
- Patients on medication known to interfere with the DAT or catechol O-methyltransferase inhibitors, or with dopamine receptor blocking / or catecholamine re-uptake blocking properties.
- Patients suffering from dystonia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
correlation between SUV to DTI measurements
Time frame: 24 months
non interventional study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Groshar, MD principal investigator
Head of nuclear medicine unit in Assuta Medical Centers
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Parkinson's Disease, run by david groshar.
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 8 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 17 Jun 2016. 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?
Contact David Groshar, MD (+972-37645497, davidg@assuta.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between SUV to DTI measurements (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2016.