PEA: FDG-PET in the Diagnosis of Autoimmune Encephalitis

• Sponsor: University of Milano Bicocca (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06019975
• Collaborator: (none)
• Enrollment: 50
• Locations: 3
• Anticipated Duration (Months): 8
• Patients Per Site: 16.7
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Encephalitis	Diagnostic Test: FDG-PET

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: FDG-PET in the Diagnosis of Autoimmune Encephalitis
• Actual Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Sep 30, 2023
• Anticipated Study Completion Date: Oct 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Autoimmune Encephalitis patients Patients with autoimmune encephalitis admitted to the centers, who underwent a brain FDG-PET during the course of their disease trajectory.	Diagnostic Test: FDG-PET; Brain FDG-PET

Outcome Measures

Primary Outcome Measures

1. SPM analysis of brain metabolic pattern [up to 6 months]

   Pattern of brain metabolism in patients with autoimmune encephalitis compared with healthy controls and patients with Alzheimer's disease, drawn from validated published databases

Secondary Outcome Measures

1. Sensitivity of basal ganglia hypermetabolism [up to 6 months]

   Sensitivity of basal ganglia hypermetabolism for the diagnosis of autoimmune encephalitis

2. Diagnostic delay [up to 6 months]

   Comparison of diagnostic delay with and without FDG-PET

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione IRCCS San Gerardo dei Tintori	Monza	Monza E Della Brianza	Italy	20900
2	Fondazione IRCCS Istituto Neurologico "Carlo Besta"	Milano		Italy	20133
3	Ospedale San Paolo	Milano		Italy	20142

Sponsors and Collaborators

• University of Milano Bicocca

Investigators

• Principal Investigator: Simone Beretta, MD, PhD, University of Milano Bicocca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Milano Bicocca
• ClinicalTrials.gov Identifier: NCT06019975
• Other Study ID Numbers: PEA
• First Posted: Aug 31, 2023
• Last Update Posted: Aug 31, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Milano Bicocca: Autoimmune Encephalitis; FDG-PET; SPM
• Additional relevant MeSH terms: Encephalitis; Autoimmune Diseases of the Nervous System; Hashimoto Disease

Study Results

No Results Posted as of Aug 31, 2023