[18F]-DPA-714 PET to detect brain inflammation in autoimmune encephalitis

Is [18F]-DPA-714 PET a Good Marker of Neuroinflammation in Autoimmune Encephalitis?

This test tries to see if [18F]-DPA-714 PET scans can detect brain inflammation in adults newly diagnosed with autoimmune encephalitis.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University Hospital, Toulouse (Academic / other)
• Locations: 1 site (Toulouse)
• Trial ID: NCT07488117 on ClinicalTrials.gov

What this trial studies

Autoimmune encephalitis is a heterogeneous group of disorders whose diagnosis can be difficult using MRI and CSF alone. This study uses a 60-minute dynamic PET scan after injection of [18F]-DPA-714, a tracer that binds the 18-kDa translocator protein (TSPO) linked to neuroimmune activity. Participants will receive clinical evaluation, MRI, and lumbar puncture as part of standard care, and PET results will be compared with healthy controls and conventional biomarkers. The goal is to characterize in vivo neuroinflammation at disease onset and determine whether PET adds diagnostic information.

Who should consider this trial

Good fit: Adults 18–80 years old with a recent (under 6 months) diagnosis meeting 'possible' autoimmune encephalitis criteria with identified antibodies, who have not received second-line immunosuppressive therapy and who have a high or mixed TSPO binding affinity, are the intended participants.

Not a fit: People who are pregnant, have MRI contraindications, have received second-line immunosuppression, have low TSPO binding affinity, have a known allergy to [18F]-DPA-714, or have paraneoplastic syndrome after immune checkpoint inhibitors are unlikely to benefit.

Why it matters

Potential benefit: If successful, this imaging could give clinicians a more direct way to see brain immune activity and help start the right treatment sooner.

How similar studies have performed: TSPO-targeted PET tracers have shown promising but variable results in other neuroinflammatory disorders, and using [18F]-DPA-714 specifically for autoimmune encephalitis is relatively new.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

* Pregnant women;
* contraindications to MRI;
* known allergic reaction to \[18F\]-DPA-714; legal protection measure;
* paraneoplastic syndrome following immune checkpoint inhibitor therapy.

Where this trial is running

Toulouse

• University Hospital — Toulouse, France (Recruiting)

Study contacts

• Study coordinator: Marie Rafiq, MD

Conditions Autoimmune Encephalitis