Optic NeuritisCOCONNCT04793087
Post-COntrast 3D SE T1 Versus Coronal SE T1-WI MRI in Detecting Optic Neuritis (COCON)
An observational study of Optic Neuritis and Multiple Sclerosis, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
3D FLAIR, 3D T1 FAT SAT, coronal T2 and coronal T1 dixon sequences were usually used to assess visual deficits in MRI. Optic nerve examination is preferably performed using a coronal T2 sequence in order to detect a hypersignal suggestive of inflammation whereas brain examination is preferably performed using a 3D T1… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Optic Neuritis, Multiple Sclerosis
- What is being tested?
- Magnetic Resonance Imaging
- How many people
- 1,200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 30 Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with visual acuity loss explored by MRI between january 2018 and january 2020
Who may be able to join
- Age > 18 years
- Decrease in visual acuity explored in MRI between january 2018 and january 2020
Who cannot join
- Past history of episode of Optic neuritis
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Fondation Adolphe de Rothschild
Paris, Île-de-France Region, 75019
About this study
Official title: Post-COntrast 3D SE T1 Versus Coronal SE T1-WI MRI in Detecting Optic Neuritis in Patients Presenting With Acute Visual Loss and Otherwise Normal Ophthalmological Examination
3D FLAIR, 3D T1 FAT SAT, coronal T2 and coronal T1 dixon sequences were usually used to assess visual deficits in MRI. Optic nerve examination is preferably performed using a coronal T2 sequence in order to detect a hypersignal suggestive of inflammation whereas brain examination is preferably performed using a 3D T1 sequence to highlight signs of spatial dissemination and lesions suggestive of multiple slerosis (MS). No study has yet investigated the detection capabilities of 3D T1 for the detection of optic nerve inflammation. The objective of this retrospective study was to determine whether a single 3D T1 sequence allows simultaneous exploration of the optic nerve and the brain for the positive diagnosis of optic neuropathy and/or MS.
- Conditions
- Optic Neuritis, Multiple Sclerosis
- Being tested
- Magnetic Resonance Imaging
- Medical subject headings
- Optic Neuritis, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDiagnostic test
Comparing 3D T1 versus coronal T1 MRI in detecting Optic Neuritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of optic neuropathies using MRI
MRI comparison of the diagnostic performance of the 3D T1 sequence and the T1 coronal in the detection of optic neuropathies.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Jan 2018
- Primary completion1 Jan 2018
- Study completion30 Aug 2020
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.
- 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
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793087
- Sponsor's protocol ID
- CE_20200204_2_ALR
- Acronym
- COCON
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 15 Mar 2021
- 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 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-COntrast 3D SE T1 Versus Coronal SE T1-WI MRI in Detecting Optic Neuritis in Patients Presenting With Acute Visual Loss and Otherwise Normal Ophthalmological Examination
- ClinicalTrials.gov ID
- NCT04793087
- Acronym / sponsor ID
- COCON / CE_20200204_2_ALR
- Conditions
- Optic Neuritis, Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 11 Mar 2021 (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.
3D FLAIR, 3D T1 FAT SAT, coronal T2 and coronal T1 dixon sequences were usually used to assess visual deficits in MRI. Optic nerve examination is preferably performed using a coronal T2 sequence in order to detect a hypersignal suggestive of inflammation whereas brain examination is preferably performed using a 3D T1 sequence to highlight signs of spatial dissemination and lesions suggestive of multiple slerosis (MS). No study has yet investigated the detection capabilities of 3D T1 for the detection of optic nerve inflammation. The objective of this retrospective study was to determine whether a single 3D T1 sequence allows simultaneous exploration of the optic nerve and the brain for the positive diagnosis of optic neuropathy and/or MS.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with visual acuity loss explored by MRI between january 2018 and january 2020
Key inclusion criteria (2 listed)
- Age > 18 years
- Decrease in visual acuity explored in MRI between january 2018 and january 2020
Key exclusion criteria (1 listed)
- Past history of episode of Optic neuritis
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 |
|---|---|---|
| Magnetic Resonance ImagingComparing 3D T1 versus coronal T1 MRI in detecting Optic Neuritis | Diagnostic test | – |
Primary outcome
Detection of optic neuropathies using MRI
Time frame: 1 hour
MRI comparison of the diagnostic performance of the 3D T1 sequence and the T1 coronal in the detection of optic neuropathies.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Optic Neuritis and Multiple Sclerosis, run by Fondation Ophtalmologique Adolphe de Rothschild 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 2 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: finished, as of the sponsor's last update on 15 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of optic neuropathies using MRI (time frame: 1 hour). 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 15 Mar 2021.