Prognostic Values of PET Examination With 11 C-Fe_CIT With Voxel-based Analysis Method in Patients With Sporadic Parkonson's Disease and Parkinsonisms (Prot.PD-diagn).

The role of PET for the in vivo study of the presynaptic dopaminergic system with 11C-Fe-CIT is universally recognized, and its use has also become routine in numerous nuclear medicine centers in Europe. The indication for the examination is provided exclusively by the clinic in the presence of extrapyramidal signs in the suspicion of Parkinson's disease (PD) or for the differential diagnosis of parkinsonisms. The existence of factors that influence the prognosis of patients with PD or parkinsonism associated with other degenerative diseases is known.

Given these premises, the possibility of identifying the disease in the early stages appears fundamental.

For this purpose the following should be considered:

1. an automatic analysis method based on the measurement of radiotracer uptake at the level of individual voxels, following Statistical Parametric Mapping procedures.
2. the analysis based on regions of interest (ROIs) positioned ad hoc by the operator which will give the value of the ROI to reference region ratio. In particular, ROIs on the basal ganglia (caudate, putamen) towards cerebellum.

Both of these methods offer a quantitative measurement of the damage at the level of the structures involved that is absolutely better than the visual investigation of the distribution of radioactivity in the central nervous system.

In this study the investigators want to compare results provided by methods 1 and 2 in the populations under examination to evaluate the data relating to the specificity and sensitivity of the test.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Diagnostic test: PET with 11C-Fe-CIT

• Study Type: Observational
• Enrollment (Actual): 300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients will be selected to be evaluated with 11C-Fe-CIT PET: Over the age of 18 years, with a diagnosis of initial PD or parkinsonism and at the time of the PET study, patients will express their written consent for the anonymous use of the data relating to their 11C-Fe-CIT' examination for scientific purposes.

Description

Inclusion Criteria:

• Diagnosed with initial PD or parkinsonism;
• signature of informed consent.

Exclusion Criteria:

• patients < 18 years

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PET11C-Fe_CIT method for the staging of patients with Parkinson.	All patients undergo to 11C Fe CIT PET examination and the data will be analyzed with ROI and SPM voxel based and correlated with neurological data.	2 years

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2008
• Primary Completion (Actual): July 15, 2009
• Study Completion (Actual): July 15, 2009

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Estimated): December 14, 2023

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Parkinsonian Disorders
• Other Study ID Numbers: PD-DIAHN/08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No