Identifying New Biomarkers of Parkinson's From Routine Brain Imaging

• Sponsor: University of Plymouth (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04986020
• Collaborator: (none)
• Enrollment: 20,000
• Anticipated Duration (Months): 35

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Diagnostic Test: MRI

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

• Study Type: Observational
• Anticipated Enrollment: 20000 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Identifying New Biomarkers of Parkinson's From Routine Brain Imaging
• Anticipated Study Start Date: Aug 1, 2021
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Parkinson disease Participants with a clinical diagnosis of Parkinson's disease	Diagnostic Test: MRI; Identification of novel biomarkers from MRI
Control Controls	Diagnostic Test: MRI; Identification of novel biomarkers from MRI

Outcome Measures

Primary Outcome Measures

1. The presence of novel putative biomarkers of future PD development as defined by a deep-learning method [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• A clinical diagnosis of Parkinson's

Exclusion Criteria:

• No clinical diagnosis of Parkinson's

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Plymouth

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jun 11, 2021

More Information

Publications

None provided.

• Responsible Party: Stephen Mullin, Clinical Lecturer in Neurology, University of Plymouth
• ClinicalTrials.gov Identifier: NCT04986020
• Other Study ID Numbers: 2557; IRAS 280243
• First Posted: Aug 2, 2021
• Last Update Posted: Aug 2, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Parkinson Disease

Study Results

No Results Posted as of Aug 2, 2021