Parkinson DiseaseNCT04986020
Identifying New Biomarkers of Parkinson's From Routine Brain Imaging
An observational study of Parkinson Disease, run by University of Plymouth.
Trial summary
The study will use routine computer tomography (CT), magnetic resonance spectroscopy (MRI) and nuclear medicine (NM) brain imaging data to produce new diagnostic tests for the onset of Parkinson's disease. This will enable hopefully earlier diagnosis than is currently possible. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- MRI
- How many people
- 20,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 1 Jul 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants drawn from the catchment areas of participating healthcare organisations
Who may be able to join
- A clinical diagnosis of Parkinson's
Who cannot join
- No clinical diagnosis of Parkinson's
Trial locations and contacts
No sites are listed yet.
About this study
The study will use routine computer tomography (CT), magnetic resonance spectroscopy (MRI) and nuclear medicine (NM) brain imaging data to produce new diagnostic tests for the onset of Parkinson's disease. This will enable hopefully earlier diagnosis than is currently possible. This will entail the analysis of anonymised CT/MRI/NM brain images collected prior to the point when these subjects were diagnosed with PD.
Read the detailed description
We intend to use historical CT/MRI/nuclear medicine brain scans to identify novel imaging biomarkers of prodromal Parkinson's disease. The primary data source for the study will be MRI and CT brain scans, whilst nuclear medicine imaging brain imaging (DAT scans) will be used to validate models produced and provide a functional outcome measure of brain dopamine uptake. We shall utilise a an artificial intelligence approach to compare scans of PD cases with matched controls in order to identify these imaging biomarkers.
A list of participants with a diagnosis will be compiled. This list, together with relevant clinical data, will be linked with historical CT/MRI/nuclear medicine scans carried out over the preceding years. A control group of matched non-PD scans will also be compiled.
The dataset will be anonymised and a bespoke ML pipeline will be used to identify imaging featureswhich may be indicative of prodromal PD. This initial stage will be carried out at University Hospital Plymouth NHS Trust (UHPNT), the Royal Cornwall Hospital NHS Trust (RCHNT) and Cornwall Partnership NHS Trust (CPNT). If successful, findings will be validated in a larger sample of scans compiled from hospitals regionally and nationally.
- Conditions
- Parkinson Disease
- Being tested
- MRI
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Identification of novel biomarkers from MRI
| Study group | Role | What they receive |
|---|---|---|
| Parkinson disease | Participants with a clinical diagnosis of Parkinson's disease Receives: Diagnostic Test: MRI | |
| Control | Controls Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of novel putative biomarkers of future PD development as defined by a deep-learning method
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Mullin, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986020
- Sponsor's protocol ID
- 2557
- Other IDs
- IRAS 280243
- Status last verified
- Jul 2021
- First submitted
- 21 Jul 2021
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying New Biomarkers of Parkinson's From Routine Brain Imaging
- ClinicalTrials.gov ID
- NCT04986020
- Acronym / sponsor ID
- 2557
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 2 Aug 2021 (actual)
- 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.
The study will use routine computer tomography (CT), magnetic resonance spectroscopy (MRI) and nuclear medicine (NM) brain imaging data to produce new diagnostic tests for the onset of Parkinson's disease. This will enable hopefully earlier diagnosis than is currently possible. This will entail the analysis of anonymised CT/MRI/NM brain images collected prior to the point when these subjects were diagnosed with PD.
Detailed description
We intend to use historical CT/MRI/nuclear medicine brain scans to identify novel imaging biomarkers of prodromal Parkinson's disease. The primary data source for the study will be MRI and CT brain scans, whilst nuclear medicine imaging brain imaging (DAT scans) will be used to validate models produced and provide a functional outcome measure of brain dopamine uptake. We shall utilise a an artificial intelligence approach to compare scans of PD cases with matched controls in order to identify these imaging biomarkers.
A list of participants with a diagnosis will be compiled. This list, together with relevant clinical data, will be linked with historical CT/MRI/nuclear medicine scans carried out over the preceding years. A control group of matched non-PD scans will also be compiled.
The dataset will be anonymised and a bespoke ML pipeline will be used to identify imaging featureswhich may be indicative of prodromal PD. This initial stage will be carried out at University Hospital Plymouth NHS Trust (UHPNT), the Royal Cornwall Hospital NHS Trust (RCHNT) and Cornwall Partnership NHS Trust (CPNT). If successful, findings will be validated in a larger sample of scans compiled from hospitals regionally and nationally.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson disease | – | Diagnostic Test: MRIParticipants with a clinical diagnosis of Parkinson's disease |
| Control | – | Diagnostic Test: MRIControls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants drawn from the catchment areas of participating healthcare organisations
Key inclusion criteria (1 listed)
- A clinical diagnosis of Parkinson's
Key exclusion criteria (1 listed)
- No clinical diagnosis of Parkinson's
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIIdentification of novel biomarkers from MRI | Diagnostic test | Control, Parkinson disease |
Primary outcome
The presence of novel putative biomarkers of future PD development as defined by a deep-learning method
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University of Plymouth.
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 1 inclusion and 1 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 2 Aug 2021. 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 Stephen Mullin, MRCP. PhD. (01752764487, stephen.mullin@plymouth.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presence of novel putative biomarkers of future PD development as defined by a deep-learning method (time frame: 3 years). 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 2 Aug 2021.