NCT05080296

Brief Summary

The diagnosis of Parkinson's disease (PD) relies mainly on clinical observation of the patient, looking for the three characteristic symptoms and sometimes remains a real challenge. Machine Learning (ML) algorithms could help to diagnose PD early and differentiate idiopathic PD from atypical Parkinsonian syndromes. In this context, the work of Castillo-Barnes' team provided a set of imaging features based on morphological characteristics extracted from DaTSCAN® or Ioflupane (iodine-123-labeled radiopharmaceutical) single-photon emission computed tomography (SPECT) scans to discern healthy participants from participants with Parkinson's disease in a balanced set of SPECTs from the "Parkinson's Progression Markers Initiative" (PPMI) data base. The team of a study evaluated the classification performance of Parkinson's patients and normal controls when semi-quantitative indicators and shape features obtained on the dopamine transporter (DAT) by Ioflupane (123I-IP) single-photon emission computed tomography (SPECT) are combined as a machine learning (ML) feature. Artificial Intelligence (AI) based methods can improve diagnostic assessments. Several dopaminergic imaging studies using Artificial have reported accuracy of up to 90% for the diagnosis of PD. These automated approaches use machine learning methods, based on textural analyses, to (i) differentiate PD and healthy subjects, (ii) differentiate PD and vascular parkinsonism, and (iii) distinguish between different forms of atypical parkinsonism. A study conducted in 2 centers using a linear support vector machine (SVM) model discriminated patients with PD and healthy subjects with an accuracy of 82.5%.This performance is similar to visual assessment by nuclear physicians A linear SVM model based on voxel values of statistical parametric images was able to differentiate PD from vascular parkinsonism with an accuracy of 90.4%. The Nancy team has extensive experience in the detection of PD in SPECT and SPECT/CT scans with Ioflupane or DaTSCAN™

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,664

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 20, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

1.4 years

First QC Date

September 30, 2021

Last Update Submit

June 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Accuracy of the algorithm

    Accuracy of the algorithm implemented for the new data in terms of predicting the type of atypical parkinsonian syndrome.

    2 months

Secondary Outcomes (2)

  • Comparison of two networks

    2 months

  • Analyze the robustness of the network

    2 months

Study Arms (1)

All patients underwent DaTSCAN SPECT scans

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All Patients who performed a DaTSCAN SPECT scan in the nuclear medicine department of the Nancy CHRU between 21/11/2011 and 01/09/2017.

You may qualify if:

  • Patients who performed a DaTSCAN SPECT scan in the nuclear medicine department of the Nancy CHRU between 21/11/2011 and 01/09/2017.
  • Reviews that took place between 11/21/2011 and 9/1/2017 were repatriated from PACS to the processing consoles.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuclear medicine department CHRU de NANCY

Vandœuvre-lès-Nancy, 54511, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 30, 2021

First Posted

October 15, 2021

Study Start

December 20, 2021

Primary Completion

May 1, 2023

Study Completion

September 1, 2024

Last Updated

June 25, 2026

Record last verified: 2026-06

Locations