Auto-immune EncephalitisNCT04339205
Diffusion Imaging in Acute Auto-immune Encephalitis
An observational study of Auto-immune Encephalitis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The aim of this non randomised retrospective study is to investigate the imaging (MRI) of auto-immune encephalitis at presentation, especially in diffusion-weighted sequences. Indeed, few series describe the MRI aspect of auto-immune at their beginning. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Auto-immune Encephalitis
- What is being tested?
- Analysis of every MRI at presentation of the symptoms and then over a period of 3 to 24 months if available.
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2020to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with auto-immune encephalitis
Who may be able to join
- Auto-immune encephalitis proved by biological results (blood and/or CSF sample)
Who cannot join
- No MRI available
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Pierre-Bénite, 69310
François COTTON, PhD
Géraldine PICARD, 04 72 35 58 42, geraldine.picard@chu-lyon.fr
About this study
Official title: Diffusion Imaging in Acute Auto-immune Encephalitis : a Cohort of 80 Patients
The aim of this non randomised retrospective study is to investigate the imaging (MRI) of auto-immune encephalitis at presentation, especially in diffusion-weighted sequences.
Indeed, few series describe the MRI aspect of auto-immune at their beginning. Recognize early MRI abnormalities seen in auto-immune encephalitis could help reduce the time to positive diagnosis and improve the therapeutic management.
- Conditions
- Auto-immune Encephalitis
- Being tested
- Analysis of every MRI at presentation of the symptoms and then over a period of 3 to 24 months if available.
- Keywords
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of every MRI at presentation of the symptoms and then over a period of 3 to 24 months if available.Other
The radiologist will analyze the MRI of patients with proved auto-immune encephalitis realized at presentation of the symptoms. If available, the following-up MRIs will also be analyzed.
At each assessment, four MRI sequences will be studied : diffusion, T2-weighted, susceptibility sensitive sequences, and T1 weighted after contrast enhanced with gadolinium.
The radiologist will analyse the signal abnormalities, their localisation and the trophicity of the brain.
We will then correlate the following clinical data collected for patients : age, sex, clinical presentation, clinical evolution, and tumor associated or not.
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI characterization, especially in Diffusion-weighted magnetic resonance imaging (DWI-MRI), of auto-immune encephalitis at presentation.
The radiologist will analyze the MRI of patients with proved auto-immune encephalitis realized at presentation of the symptoms. If available, the following-up MRIs will also be analyzed.
At each assessment, four MRI sequences will be studied : diffusion, T2-weighted, susceptibility sensitive sequences, and T1 weighted after contrast enhanced with gadolinium.
The radiologist will analyse the signal abnormalities, their localisation and the trophicity of the brain.
We will then correlate the following clinical data collected for patients : age, sex, clinical presentation, clinical evolution, and tumor associated or not.
Measured: at following-up until 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start1 Feb 2020
- Primary completion1 Mar 2020
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auto-immune EncephalitisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339205
- Sponsor's protocol ID
- Imaging study
- Status last verified
- Jun 2020
- First submitted
- 6 Apr 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion Imaging in Acute Auto-immune Encephalitis : a Cohort of 80 Patients
- ClinicalTrials.gov ID
- NCT04339205
- Acronym / sponsor ID
- Imaging study
- Conditions
- Auto-immune Encephalitis
- Keywords
- MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 9 Apr 2020 (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.
The aim of this non randomised retrospective study is to investigate the imaging (MRI) of auto-immune encephalitis at presentation, especially in diffusion-weighted sequences.
Indeed, few series describe the MRI aspect of auto-immune at their beginning. Recognize early MRI abnormalities seen in auto-immune encephalitis could help reduce the time to positive diagnosis and improve the therapeutic management.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with auto-immune encephalitis
Key inclusion criteria (1 listed)
- Auto-immune encephalitis proved by biological results (blood and/or CSF sample)
Key exclusion criteria (1 listed)
- No MRI available
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 |
|---|---|---|
| Analysis of every MRI at presentation of the symptoms and then over a period of 3 to 24 months if available.The radiologist will analyze the MRI of patients with proved auto-immune encephalitis realized at presentation of the symptoms. If available, the following-up MRIs will also be analyzed. At each assessment, four MRI sequences will be studied : diffusion, T2-weighted, susceptibility sensitive sequences, and T1 weighted after contrast enhanced with gadolinium. The radiologist will analyse the signal abnormalities, their localisation and the trophicity of the brain. We will then correlate the following clinical data collected for patients : age, sex, clinical presentation, clinical evolution, and tumor associated or not. | Other | – |
Primary outcome
MRI characterization, especially in Diffusion-weighted magnetic resonance imaging (DWI-MRI), of auto-immune encephalitis at presentation.
Time frame: at following-up until 24 months
The radiologist will analyze the MRI of patients with proved auto-immune encephalitis realized at presentation of the symptoms. If available, the following-up MRIs will also be analyzed. At each assessment, four MRI sequences will be studied : diffusion, T2-weighted, susceptibility sensitive sequences, and T1 weighted after contrast enhanced with gadolinium. The radiologist will analyse the signal abnormalities, their localisation and the trophicity of the brain. We will then correlate the following clinical data collected for patients : age, sex, clinical presentation, clinical evolution, and tumor associated or not.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Individual participant dataSharing planned: No
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Active, not recruitingObservational study
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Paraneoplastic Neurological Syndrome, Autoimmune Encephalitis
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Auto-immune Encephalitis, run by Hospices Civils de Lyon 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Jul 2020. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François cotton, phd (04 78 56 91 00, francois.cotton@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI characterization, especially in Diffusion-weighted magnetic resonance imaging (DWI-MRI), of auto-immune encephalitis at presentation. (time frame: at following-up until 24 months). 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 1 Jul 2020.