Autoimmune Encephalitis (AE)Phase 2EAI-714NCT07488117
Is [18F]-DPA-714 PET a Good Marker of Neuroinflammation in Autoimmune Encephalitis?
A Phase 2 study testing TEP with radioligand EAI 714 in people with Autoimmune Encephalitis (AE), run by University Hospital, Toulouse at 1 site in France.
Trial summary
This study aims to evaluate the effectiveness of [18F]-DPA-714 PET imaging in detecting neuroimmune activity in patients with autoimmune encephalitis (AE). The primary objective is to compare [18F]-DPA-714 binding in AE patients to healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Encephalitis (AE)
- What is being tested?
- TEP with radioligand EAI 714
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2026to Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant women;
- contraindications to MRI;
- known allergic reaction to [18F]-DPA-714; legal protection measure;
- paraneoplastic syndrome following immune checkpoint inhibitor therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital
Toulouse
Marie RAFIQ, MD, rafiq.m@chu-toulouse.fr
Marie rafiq, MD
About this study
This study aims to evaluate the effectiveness of [18F]-DPA-714 PET imaging in detecting neuroimmune activity in patients with autoimmune encephalitis (AE). The primary objective is to compare [18F]-DPA-714 binding in AE patients to healthy controls.
Read the detailed description
Autoimmune encephalitis (AIE) constitutes a heterogeneous group of rare diseases affecting the central nervous system. They are distinguished by the presence of different antibody types and clinical manifestations. The diagnosis is inherently challenging due to the heterogeneity of symptoms, yet it is of paramount importance for the expeditious initiation of treatment. The current diagnostic criteria, established in 2016, define AIS as follows: possible, definite and seronegative. However, these criteria have limitations in terms of sensitivity and specificity. Furthermore, the diagnostic tools that are typically employed to detect inflammatory abnormalities in the central nervous system (brain MRI and analysis of CSF) are frequently inadequate in this condition. Positron emission tomography (PET) imaging targeting the 18-kDa translocator protein (TSPO) is emerging as a promising approach for the in vivo assessment of neuro-immune activity in EAI.
The objective of the proposed research project is to examine neuro-immune activity on PET imaging at the onset of EAI. The procedure involves a 60-minute dynamic PET scan immediately after [18F]-DPA-714 injection. Patients will undergo clinical evaluation, MRI, and lumbar puncture as part of their standard care. Follow-up will include analysis of PET images, comparison with healthy controls, and comparison between PET results and conventional biomarkers (MRI, CSF analysis).
- Conditions
- Autoimmune Encephalitis (AE)
- Being tested
- TEP with radioligand EAI 714
- Medical subject headings
- Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEP with radioligand EAI 714Other
60-minutes [18F]-DPA-714 PET imaging
| Study group | Role | What they receive |
|---|---|---|
| patients with Autoimmune encephalitis | Experimental | patients with Autoimmune encephalitis Receives: Other: TEP with radioligand EAI 714 |
| control | Experimental | control Receives: Other: TEP with radioligand EAI 714 |
What is being measured
The primary outcome is the main question the study is designed to answer.
binding potential (BP) in AE patients
Whole-brain [18F]-DPA-714 binding potential (BP) in AE patients compared to healthy controls.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start31 Mar 2026
- Primary completionJun 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Encephalitis (AE)Studies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The diagnostic is made with a radioligand (EAI 714) during the TEP This is the Drug for the study, But the aim of the study is diagnostic
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488117
- Sponsor's protocol ID
- RC31/24/0569
- Other IDs
- 2025-522768-33-00, 2025
- Acronym
- EAI-714
- Status last verified
- May 2026
- First submitted
- 10 Mar 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is [18F]-DPA-714 PET a Good Marker of Neuroinflammation in Autoimmune Encephalitis?
- ClinicalTrials.gov ID
- NCT07488117
- Acronym / sponsor ID
- EAI-714 / RC31/24/0569
- Conditions
- Autoimmune Encephalitis (AE)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effectiveness of [18F]-DPA-714 PET imaging in detecting neuroimmune activity in patients with autoimmune encephalitis (AE). The primary objective is to compare [18F]-DPA-714 binding in AE patients to healthy controls.
Detailed description
Autoimmune encephalitis (AIE) constitutes a heterogeneous group of rare diseases affecting the central nervous system. They are distinguished by the presence of different antibody types and clinical manifestations. The diagnosis is inherently challenging due to the heterogeneity of symptoms, yet it is of paramount importance for the expeditious initiation of treatment. The current diagnostic criteria, established in 2016, define AIS as follows: possible, definite and seronegative. However, these criteria have limitations in terms of sensitivity and specificity. Furthermore, the diagnostic tools that are typically employed to detect inflammatory abnormalities in the central nervous system (brain MRI and analysis of CSF) are frequently inadequate in this condition. Positron emission tomography (PET) imaging targeting the 18-kDa translocator protein (TSPO) is emerging as a promising approach for the in vivo assessment of neuro-immune activity in EAI.
The objective of the proposed research project is to examine neuro-immune activity on PET imaging at the onset of EAI. The procedure involves a 60-minute dynamic PET scan immediately after [18F]-DPA-714 injection. Patients will undergo clinical evaluation, MRI, and lumbar puncture as part of their standard care. Follow-up will include analysis of PET images, comparison with healthy controls, and comparison between PET results and conventional biomarkers (MRI, CSF analysis).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The diagnostic is made with a radioligand (EAI 714) during the TEP This is the Drug for the study, But the aim of the study is diagnostic
| Arm | Type | Receives |
|---|---|---|
| patients with Autoimmune encephalitis | Experimental | Other: TEP with radioligand EAI 714patients with Autoimmune encephalitis |
| control | Experimental | Other: TEP with radioligand EAI 714control |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Pregnant women;
- contraindications to MRI;
- known allergic reaction to [18F]-DPA-714; legal protection measure;
- paraneoplastic syndrome following immune checkpoint inhibitor therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEP with radioligand EAI 71460-minutes [18F]-DPA-714 PET imaging | Other | control, patients with Autoimmune encephalitis |
Primary outcome
binding potential (BP) in AE patients
Time frame: Baseline
Whole-brain [18F]-DPA-714 binding potential (BP) in AE patients compared to healthy controls.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TEP with radioligand EAI 714 in people with Autoimmune Encephalitis (AE), run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Rafiq, MD (+33 561779491, rafiq.m@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
binding potential (BP) in AE patients (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.