N,N-DIETHYL-(2-(4-(2-(18F)FLUOROETHOXY)PHENYL)-5,7-DIMETHYLPYRAZOLO(1,5-A)PYRIMIDINE-3-YL)ACETAMIDE for Autoimmune encephalitis

Inclusion criteria

• {"criterion_text":"- Age 18-80 years\n- meeting clinical criteria for \"possible\" AE with identified antibodies; newly diagnosed with symptoms <6 months\n- no second-line immunosuppressive treatment;\n- high or mixed TSPO binding affinity phenotype."}

Exclusion criteria

• {"criterion_text":"- Pregnant women\n- contraindications to MRI\n- known allergic reaction to [18F]-DPA-714\n- legal protection measure\n- paraneoplastic syndrome following immune checkpoint inhibitor therapy."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint will be the value of the «Binding Potential» (BP) of DPA-714 at the whole brain scale calculated by an automated clustering method in supervised cluster analysis (SVCA).","definition_or_measurement_approach":"Value of Binding Potential (BP) of DPA-714 at whole-brain scale calculated by an automated clustering method in supervised cluster analysis (SVCA)."}

Secondary endpoints

• {"endpoint_text":"- The BPs of regions of interest will be compared between patients and controls.","definition_or_measurement_approach":"Regional Binding Potentials (BPs) compared between autoimmune encephalitis patients and healthy controls."}
• {"endpoint_text":"- The result of imaging [18F]-DPA-714 in PET will be, for each participant, dichotomized into 2: positive and negative. A result will be classified as \"positive\" if at least one region of interest has a BP greater than 2-DS compared to the average of control participants as done in the study by Zhang et al., 2024. The percentage of patients with a positive result will be calculated.","definition_or_measurement_approach":"Dichotomous classification per participant: 'positive' if ≥1 ROI BP > 2 standard deviations above control mean (per Zhang et al., 2024); percentage of patients positive will be reported."}
• {"endpoint_text":"- The results of other biomarkers conventionally used for the diagnosis of AIE will also be divided into 'positive' and 'negative'. Patients will be classified into positive/negative according to each biomarker to identify the most effective biomarker.","definition_or_measurement_approach":"Conventional diagnostic biomarkers (e.g., MRI, CSF analysis) dichotomized into positive/negative; classification by biomarker to identify most effective."}
• {"endpoint_text":"- Finally, a linear regression analysis will be performed between the overall BP of patients and clinical severity scores","definition_or_measurement_approach":"Linear regression between overall patient BP and clinical severity scores."}
• {"endpoint_text":"- We will make a description of a possible concordance between the BP by region of interest and the presence of identified symptoms","definition_or_measurement_approach":"Descriptive analysis of concordance between regional BP and patient symptoms."}

France

Earliest CTIS Part Ii Submission Date

04-12-2025

Latest Decision Or Authorization Date

15-12-2025

Processing Time Days

11

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Toulouse

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France