Identifying New Biomarkers of Parkinson's From Routine Brain Imaging

• Conditions: Parkinson Disease
• Interventions: Diagnostic Test: MRI

• Registration Number: NCT04986020
• Lead Sponsor: University of Plymouth

Brief 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. 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 Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-21
• Study First Submitted QC: 2021-07-21
• Last Update Submitted: 2021-07-21
• Study Start: 2021-08-01
• Study First Posted: 2021-08-02
• Last Update Posted: 2021-08-02
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

• A clinical diagnosis of Parkinson's

Exclusion Criteria

• No clinical diagnosis of Parkinson's

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parkinson disease	MRI	Participants with a clinical diagnosis of Parkinson's disease
Control	MRI	Controls

Primary Outcome Measures

Name	Time	Method
The presence of novel putative biomarkers of future PD development as defined by a deep-learning method	3 years