ClinicalTrials.gov record NCT07488117

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old to 80 years old
SexAll
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 2 diagnostic study tests whether a 60-minute [18F]-DPA-714 PET scan can show neuro-immune activity in people with autoimmune encephalitis compared with healthy controls. Participants will have a dynamic PET scan; patients will also have MRI and lumbar puncture as part of their usual care. PET results will be compared with MRI and cerebrospinal fluid (CSF) findings.

What it is studying. The study is testing whether [18F]-DPA-714 PET imaging (measuring TSPO binding) reflects neuro-immune activity in autoimmune encephalitis and how PET findings compare with conventional biomarkers (MRI and CSF).

What the researchers hope to learn. To evaluate [18F]-DPA-714 PET as an in vivo marker of neuro-immune activity at the onset of autoimmune encephalitis; to compare PET binding measures with MRI and CSF biomarkers; to measure whole-brain [18F]-DPA-714 binding potential in patients and controls.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • TEP with radioligand EAI 714

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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).

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants undergo a 60-minute dynamic PET scan immediately after injection of the radioligand [18F]-DPA-714. Patients will also have clinical evaluation, brain MRI, and lumbar puncture (spinal tap) as part of their standard care. Healthy controls will undergo the PET scan (and assessments as defined by the study). Results from PET will be compared with MRI and cerebrospinal fluid findings for research analysis.

How the study is structured. Interventional diagnostic study with two non-randomized parallel groups (people with autoimmune encephalitis and healthy controls). Participants receive a single 60-minute dynamic [18F]-DPA-714 PET scan. The study is not masked (open-label).

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on autoimmune encephalitis

Clinical trials40 trials listed for autoimmune encephalitisEvery trial the registry lists for autoimmune encephalitis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in autoimmune encephalitis researchLatest monthly update: September 2026. Includes: Efgartigimod reports. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Mar 31, 2026
Primary completion
June 2027 (estimated)
Study completion
January 2028 (estimated)
Target enrollment
40 participants (estimated)
Last updated on registry
May 11, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University Hospital, Toulouse

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

PET
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
primary objective
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
immunosuppressive
A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
contraindications
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
lumbar puncture
A procedure in which a needle is placed between the bones of the lower back to collect spinal fluid or to give a treatment.
Follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
biomarkers
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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