Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism
Recruiting · NCT06079294 · Interventional (participants receive a specific treatment) · Lead sponsor: Assistance Publique - Hôpitaux de Paris
View the official record on ClinicalTrials.gov →Interventions studied
FDG PET
What this trial is about
Prospective cohort study evaluating FDG PET in 56 patients with confirmed autoimmune encephalitis - based on 2016 Graus criteria, and 2021 paraneoplastic neurological syndromes criteria - at the acute phase, before immunomodulating treatment, or within 10 days of treatment initiation.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age ≥ 18 years old
- Newly diagnosed autoimmune encephalitis based on at least 1 of the 3 following criteria :
- " Definite limbic autoimmune encephalitis " according to 2016 Graus et al. criteria
- " Possible autoimmune encephalitis " according to 2016 Graus et al. criteria AND typical autoantibody detected in serum or CSF
- " Probable or certain paraneoplastic neurological syndrome " according to Graus et al. 2021 criteria (excluding peripheral neurological syndromes)
- Less than 6 months since first neurological symptoms imputable to autoimmune encephalitis
- Affiliated or entitled to a social security system (except AME)
- Obtaining free, written and informed consent (patient or legal representative or the close relative)
Exclusion criteria
- History of brain tumor, head trauma, infarction or cerebral hematoma likely to result in altered cerebral carbohydrate metabolism on PET
- Patients who hae been on immunotherapy (corticosteroid bolus, IVIg, plasma exchange, endoxan, rituximab or other immunotherapy) fr more than 10 days
- Pregnant or breast-feeding woman
- Ventilated intubated patient
- Absolute contraindication to MRI (Pacemaker, cochlear implant, etc.)
- Presence of cognitive disorders incompatible with goog cooperation with the PET scan
- Algic or agitated patient unable to remain immobile in supine position for 30 minutes
- Deprived of liberty or under a protective measure (guardianship or curatorship)
- Patient taking part in other interventional research involving radiopharmaceutical injections
Where it is running
1 location listed.
- Hospital Pitie Salpetriere - Paris, France