Identifying New Biomarkers of Parkinson's From Routine Brain Imaging

NCT ID: NCT04986020

Last Updated: 2021-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2024-07-01

Brief Summary

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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

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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

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Parkinson Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Parkinson disease

Participants with a clinical diagnosis of Parkinson's disease

MRI

Intervention Type DIAGNOSTIC_TEST

Identification of novel biomarkers from MRI

Control

Controls

MRI

Intervention Type DIAGNOSTIC_TEST

Identification of novel biomarkers from MRI

Interventions

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MRI

Identification of novel biomarkers from MRI

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

\- A clinical diagnosis of Parkinson's

Exclusion Criteria

\- No clinical diagnosis of Parkinson's
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Plymouth

OTHER

Sponsor Role lead

Responsible Party

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Stephen Mullin

Clinical Lecturer in Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Stephen Mullin, MRCP. PhD.

Role: CONTACT

01752764487

Megan Courtman, MSc.

Role: CONTACT

01752764487

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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IRAS 280243

Identifier Type: OTHER

Identifier Source: secondary_id

2557

Identifier Type: -

Identifier Source: org_study_id

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