FDG-PET in the Diagnosis of Autoimmune Encephalitis

Autoimmune Encephalitis Clinical Trial

— PEA  

Official title:

FDG-PET in the Diagnosis of Autoimmune Encephalitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06019975
• Other study ID #: PEA
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: December 2023
• Source: University of Milano Bicocca
• Contact: Simone Beretta, MD, PhD
• Phone: +390392333568
• Email: simone.beretta[@]unimib.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this retrospective observational study is to compare brain fluorodeoxyglucose-positron emission tomography (FDG-PET) of patients with autoimmune encephalitis, normal controls and patients with Alzheimer's disease (AD). The main question it aims to answer is:

•is there a specific pattern of brain metabolism in patients with autoimmune encephalitis Participants data and images will be retrospectively collected from hospital records, and FDG-PET images will be analyzed by means of statistical parametric mapping (SPM). Controls will be selected from validated public databases.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of autoimmune encephalitis according to clinical criteria

• Brain magnetic resonance imaging performed between clinical presentation and treatment

• Cerebrospinal fluid analysis performed between clinical presentation and treatment

• Brain FDG-PET performed between clinical presentation and treatment

• Autoantibodies testing performed between clinical presentation and treatment

Exclusion Criteria:

• Refusal to give consent for the study

Related Conditions & MeSH terms

• Autoimmune Diseases of the Nervous System
• Autoimmune Encephalitis
• Encephalitis
• Hashimoto Disease

Intervention

Diagnostic Test:
• FDG-PET
Brain FDG-PET

Locations

Country	Name	City	State
Italy	IRCCS Ospedale Policlinico San Martino	Genova	Liguria
Italy	Fondazione IRCCS Istituto Neurologico "Carlo Besta"	Milano
Italy	Ospedale San Paolo	Milano
Italy	Fondazione IRCCS San Gerardo dei Tintori	Monza	Monza E Della Brianza
Italy	Fondazione IRCCS Mondino	Pavia	Lombardia
Italy	Azienda Sanitaria Universitaria Friuli Centrale	Udine	Friuli Venezia Giulia

Sponsors (1)

Lead Sponsor	Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SPM analysis of brain metabolic pattern	Pattern of brain metabolism in patients with autoimmune encephalitis compared with healthy controls and patients with Alzheimer's disease, drawn from validated published databases	up to 6 months
Secondary	Sensitivity of basal ganglia hypermetabolism	Sensitivity of basal ganglia hypermetabolism for the diagnosis of autoimmune encephalitis	up to 6 months
Secondary	Diagnostic delay	Comparison of diagnostic delay with and without FDG-PET	up to 6 months