Evaluating brain glucose metabolism in autoimmune encephalitis patients
Impact of Confirmed Autoimmune Encephalitis on Brain Glucose Metabolism : a Prospective FDG PET Study
This study is testing if a special brain scan can help doctors better understand how autoimmune encephalitis affects brain function in patients right before or shortly after they start treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | rituximab, immunotherapy |
| Locations | 1 site (Paris) |
| Trial ID | NCT06079294 on ClinicalTrials.gov |
What this trial studies
This prospective cohort study aims to assess the diagnostic value of FDG PET imaging in 56 patients diagnosed with autoimmune encephalitis, either seropositive or seronegative, during the acute phase of their condition. Patients will be evaluated before the initiation of immunomodulating treatment or within 10 days of starting treatment, based on established diagnostic criteria. The study will also include a follow-up PET scan three months post-treatment to analyze changes in brain glucose metabolism. The goal is to determine if FDG PET can provide better diagnostic insights compared to traditional MRI methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have recently been diagnosed with autoimmune encephalitis based on specific diagnostic criteria.
Not a fit: Patients with a history of brain tumors, head trauma, or those who have received prior immunotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early diagnosis and treatment strategies for patients with autoimmune encephalitis, potentially improving neurological outcomes.
How similar studies have performed: While FDG PET has shown promise in small retrospective studies, this prospective evaluation is novel and aims to establish its diagnostic role in autoimmune encephalitis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years old * Newly diagnosed autoimmune encephalitis based on at least 1 of the 3 following criteria : 1. " Definite limbic autoimmune encephalitis " according to 2016 Graus et al. criteria 2. " Possible autoimmune encephalitis " according to 2016 Graus et al. criteria AND typical autoantibody detected in serum or CSF 3. " 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 this trial is running
Paris
- Hospital Pitie Salpetriere — Paris, France (Recruiting)
Study contacts
- Principal investigator: Aurélie Kas, Pr — Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
- Study coordinator: Aurélie Kas, Pr
- Email: aurelie.kas@aphp.fr
- Phone: 01 42 17 62 81
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.