Multiple SclerosisCOPEQ-MSNCT04705870
Comparison of the Performance of an Optimized 3D EPI SWI Sequence and a Non-EPI QSM SWI Sequence in Detecting the Central Vein Sign in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Patients who have agreed to participate in the study will complete the MRI protocol as part of routine care, to which four additional 20-minute sequences will be added. MRI of routine care in the context of MS includes at least the following sequences: 3D T1 TFE (2 minutes) T2 TSE (2 minutes) 3D FLAIR (3 minutes) SWI… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- cerebral MRI
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2021to 24 May 2023
- 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: Patient with MS and who should undergo an MRI examination with or without injections of contrast agent as part of their care.
Who may be able to join
- Patients over 18
- With MS defined according to the McDonald's revised clinical or radiological spatial and temporal dissemination criteria, with onset of symptoms <5 years
- To benefit as part of care from an MRI with or without injection of gadolinium
- Express consent to participate in the study
- Affiliate or beneficiary of a social security scheme
Who cannot join
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Patients who have agreed to participate in the study will complete the MRI protocol as part of routine care, to which four additional 20-minute sequences will be added.
MRI of routine care in the context of MS includes at least the following sequences:
Read more
- 3D T1 TFE (2 minutes)
- T2 TSE (2 minutes)
- 3D FLAIR (3 minutes)
- SWI EPI 0.6 iso (7 minutes)
The sequences added by the search are:
- SWI non EPI QSM 6 echo (10 minutes)
- SWI EPI in resolution equivalent to non-EPI SWI (3 minutes)
- SWI EPI to TR equivalent to SWI non EPI (6 minutes)
These sequences will be acquired before or after the injection of gadolinium (if present in the examination of routine care). For examinations carried out with injection, the order of carrying out the 4 post-injection SWI sequences will be random.
- Conditions
- Multiple Sclerosis
- Being tested
- cerebral MRI
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cerebral MRIDevice
MRI of routine care in the context of MS includes at least the following sequences:
- 3D T1 TFE (2 minutes)
- T2 TSE (2 minutes)
- 3D FLAIR (3 minutes)
- SWI EPI 0.6 iso (7 minutes)
The sequences added by the search are:
- SWI non EPI QSM 6 echo (10 minutes)
- SWI EPI in resolution equivalent to non-EPI SWI (3 minutes)
- SWI EPI to TR equivalent to SWI non EPI (6 minutes)
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of lesions showing the central vein sign with the SWI EPI sequence that also show the central vein sign with the candidate sequence
Measured: 1 day
percentage of lesions which do not present the sign of the central vein with the SWI EPI sequence but which present it with the candidate sequence
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start2 Jun 2021
- Primary completion24 May 2023
- Study completion24 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- 60 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
- NCT04705870
- Sponsor's protocol ID
- JSY_2020_39
- Acronym
- COPEQ-MS
- Status last verified
- Dec 2025
- First submitted
- 11 Jan 2021
- Last updated
- 5 Jan 2026
- 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 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Performance of an Optimized 3D EPI SWI Sequence and a Non-EPI QSM SWI Sequence in Detecting the Central Vein Sign in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04705870
- Acronym / sponsor ID
- COPEQ-MS / JSY_2020_39
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 12 Jan 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.
Patients who have agreed to participate in the study will complete the MRI protocol as part of routine care, to which four additional 20-minute sequences will be added.
MRI of routine care in the context of MS includes at least the following sequences:
- 3D T1 TFE (2 minutes)
- T2 TSE (2 minutes)
- 3D FLAIR (3 minutes)
- SWI EPI 0.6 iso (7 minutes)
The sequences added by the search are:
- SWI non EPI QSM 6 echo (10 minutes)
- SWI EPI in resolution equivalent to non-EPI SWI (3 minutes)
- SWI EPI to TR equivalent to SWI non EPI (6 minutes)
These sequences will be acquired before or after the injection of gadolinium (if present in the examination of routine care). For examinations carried out with injection, the order of carrying out the 4 post-injection SWI sequences will be random.
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 with MS and who should undergo an MRI examination with or without injections of contrast agent as part of their care.
Key inclusion criteria (5 listed)
- Patients over 18
- With MS defined according to the McDonald's revised clinical or radiological spatial and temporal dissemination criteria, with onset of symptoms <5 years
- To benefit as part of care from an MRI with or without injection of gadolinium
- Express consent to participate in the study
- Affiliate or beneficiary of a social security scheme
Key exclusion criteria (2 listed)
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
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 |
|---|---|---|
| cerebral MRIMRI of routine care in the context of MS includes at least the following sequences: * 3D T1 TFE (2 minutes) * T2 TSE (2 minutes) * 3D FLAIR (3 minutes) * SWI EPI 0.6 iso (7 minutes) The sequences added by the search are: * SWI non EPI QSM 6 echo (10 minutes) * SWI EPI in resolution equivalent to non-EPI SWI (3 minutes) * SWI EPI to TR equivalent to SWI non EPI (6 minutes) | Device | – |
Primary outcome
percentage of lesions showing the central vein sign with the SWI EPI sequence that also show the central vein sign with the candidate sequence
Time frame: 1 day
percentage of lesions which do not present the sign of the central vein with the SWI EPI sequence but which present it with the candidate sequence
Time frame: 1 day
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 5 Jan 2026.
- Individual participant dataSharing planned: No
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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 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 5 inclusion and 2 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 5 Jan 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.
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?
percentage of lesions showing the central vein sign with the SWI EPI sequence that also show the central vein sign with the candidate sequence (time frame: 1 day). The study lists 2 primary outcomes in all. 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 5 Jan 2026.