Optic NeuritisQUESTIONNCT06916182
Evaluation of Optic Neuritis Using Synthetic Quantitative MRI
An observational study of Optic Neuritis, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
Inflammatory optic neuropathy (optic neuritis) is an acute condition that can affect the optic nerve along its entire course. It is a rare event, with a prevalence of up to 5 cases per 100,000 people per year, predominantly affecting young individuals (18-50 years old), primarily Caucasian and female. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Optic Neuritis
- What is being tested?
- MRI sequence
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Nov 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient requiring an MRI as part of the diagnosis of optic neuritis.
Who may be able to join
- Presenting with a painful unilateral decrease in visual acuity for less than one month
- Referred for contrast-enhanced MRI imaging
- Explicit consent for participation in the study
Who cannot join
- Ophthalmological diagnosis other than optic neuritis explaining the symptoms
- Known history of optic neuritis (same eye or contralateral eye)
- Ophthalmological history interfering with the interpretation of ophthalmologic examinations (severe myopia, retinopathy)
- Known glaucoma (same eye or contralateral eye)
- Known diabetes
- Patient under legal protection
- Pregnant or breastfeeding woman
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Inflammatory optic neuropathy (optic neuritis) is an acute condition that can affect the optic nerve along its entire course.
It is a rare event, with a prevalence of up to 5 cases per 100,000 people per year, predominantly affecting young individuals (18-50 years old), primarily Caucasian and female. The causes of optic neuropathy are diverse, with the most common being multiple sclerosis, which is the revealing condition in nearly 30% of cases.
Read more
MRI is an integral part of the initial assessment of optic neuritis, in conjunction with clinical examination, laboratory tests, and OCT (optical coherence tomography). It plays a crucial role in the acute management of this condition, particularly by guiding the etiological diagnosis and helping adapt the therapeutic approach accordingly.
The establishment of objective and reliable MRI prognostic markers could allow for more precise immediate therapeutic adjustments, thereby improving the prognosis of this potentially severe and debilitating disease, whose treatment itself is not without risks. Indeed, determining the appropriate corticosteroid dose and deciding whether to combine it with other treatments remains a current clinical challenge.
Despite various publications, MRI prognostic criteria for short- and long-term outcomes of optic neuritis remain unclear. Recent studies using radiomics have shown promising results, but these rely on limited sample sizes. New investigative methods are currently under development in the field of medical imaging, particularly "quantitative MRI."
This approach enables effective analysis through mapping techniques, which generate numerical values compared to predetermined references. For instance:
T1 (or R1) mapping assesses fibrosis and, indirectly, myelination, T2 (or R2) mapping evaluates edema. To our knowledge, this approach has never been studied for the optic nerve.
More recently, the emergence of synthetic imaging has made it possible to generate the previously mentioned R1/R2 maps, along with more conventional weighted images (T1, T2, FLAIR, DP), from a single MRI sequence (2D spin-echo sequence). This sequence provides quantitative values while maintaining a short acquisition time (~5 minutes), which is essential in ophthalmologic imaging, where motion artifacts are frequent.
The goal of this study is to identify prognostic criteria for the evolution of optic neuritis using synthetic quantitative MRI sequences, in the form of threshold numerical values.
- Conditions
- Optic Neuritis
- Being tested
- MRI sequence
- Medical subject headings
- Optic Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI sequenceOther
This sequence is a 2D spin-echo sequence for the generation of synthetic maps
What is being measured
The primary outcome is the main question the study is designed to answer.
visual function at 4 months (ordinal outcome)
Visual function will be categorized into four stages:
- Normal visual acuity , normal visual field, and OCT, with no identified sequelae.
- Normal visual acuity and visual field, but sequelae identified on OCT (ganglion cells or pRNFL).
- Normal visual acuity but an abnormal visual field.
- Persistently abnormal visual acuity.
Definitions:
Normal visual acuity:
- For bilateral optic neuritis: visual acuity ≥ 10/10.
- For unilateral optic neuritis: visual acuity ≥ that of the contralateral (unaffected) eye.
Normal visual field: Mean deviation (MD) > -3 dB.
Normal OCT (ganglion cell layer and pRNFL):
Values within the normal range according to the manufacturer's reference data, adjusted for age.
Measured: 4 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study startJun 2025 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic NeuritisStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916182
- Sponsor's protocol ID
- ALR_2024_11
- Acronym
- QUESTION
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 8 Apr 2025
- 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 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Optic Neuritis Using Synthetic Quantitative MRI
- ClinicalTrials.gov ID
- NCT06916182
- Acronym / sponsor ID
- QUESTION / ALR_2024_11
- Conditions
- Optic Neuritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Jun 2025 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 8 Apr 2025 (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.
Inflammatory optic neuropathy (optic neuritis) is an acute condition that can affect the optic nerve along its entire course.
It is a rare event, with a prevalence of up to 5 cases per 100,000 people per year, predominantly affecting young individuals (18-50 years old), primarily Caucasian and female. The causes of optic neuropathy are diverse, with the most common being multiple sclerosis, which is the revealing condition in nearly 30% of cases.
MRI is an integral part of the initial assessment of optic neuritis, in conjunction with clinical examination, laboratory tests, and OCT (optical coherence tomography). It plays a crucial role in the acute management of this condition, particularly by guiding the etiological diagnosis and helping adapt the therapeutic approach accordingly.
The establishment of objective and reliable MRI prognostic markers could allow for more precise immediate therapeutic adjustments, thereby improving the prognosis of this potentially severe and debilitating disease, whose treatment itself is not without risks. Indeed, determining the appropriate corticosteroid dose and deciding whether to combine it with other treatments remains a current clinical challenge.
Despite various publications, MRI prognostic criteria for short- and long-term outcomes of optic neuritis remain unclear. Recent studies using radiomics have shown promising results, but these rely on limited sample sizes. New investigative methods are currently under development in the field of medical imaging, particularly "quantitative MRI."
This approach enables effective analysis through mapping techniques, which generate numerical values compared to predetermined references. For instance:
T1 (or R1) mapping assesses fibrosis and, indirectly, myelination, T2 (or R2) mapping evaluates edema. To our knowledge, this approach has never been studied for the optic nerve.
More recently, the emergence of synthetic imaging has made it possible to generate the previously mentioned R1/R2 maps, along with more conventional weighted images (T1, T2, FLAIR, DP), from a single MRI sequence (2D spin-echo sequence). This sequence provides quantitative values while maintaining a short acquisition time (~5 minutes), which is essential in ophthalmologic imaging, where motion artifacts are frequent.
The goal of this study is to identify prognostic criteria for the evolution of optic neuritis using synthetic quantitative MRI sequences, in the form of threshold numerical values.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient requiring an MRI as part of the diagnosis of optic neuritis.
Key inclusion criteria (3 listed)
- Presenting with a painful unilateral decrease in visual acuity for less than one month
- Referred for contrast-enhanced MRI imaging
- Explicit consent for participation in the study
Key exclusion criteria (7 listed)
- Ophthalmological diagnosis other than optic neuritis explaining the symptoms
- Known history of optic neuritis (same eye or contralateral eye)
- Ophthalmological history interfering with the interpretation of ophthalmologic examinations (severe myopia, retinopathy)
- Known glaucoma (same eye or contralateral eye)
- Known diabetes
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 |
|---|---|---|
| MRI sequenceThis sequence is a 2D spin-echo sequence for the generation of synthetic maps | Other | – |
Primary outcome
visual function at 4 months (ordinal outcome)
Time frame: 4 months after inclusion
Visual function will be categorized into four stages: 1. Normal visual acuity , normal visual field, and OCT, with no identified sequelae. 2. Normal visual acuity and visual field, but sequelae identified on OCT (ganglion cells or pRNFL). 3. Normal visual acuity but an abnormal visual field. 4. Persistently abnormal visual acuity. Definitions: Normal visual acuity: * For bilateral optic neuritis: visual acuity ≥ 10/10. * For unilateral optic neuritis: visual acuity ≥ that of the contralateral (unaffected) eye. Normal visual field: Mean deviation (MD) > -3 dB. Normal OCT (ganglion cell layer and pRNFL): Values within the normal range according to the manufacturer's reference data, adjusted for age.
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 8 Apr 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Optic Neuritis, run by Fondation Ophtalmologique Adolphe de Rothschild.
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Amélie Yavchitz, MD-PHD (+33148036454, ayavchitz@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual function at 4 months (ordinal outcome) (time frame: 4 months after inclusion). 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 8 Apr 2025.