MRICS-QSMNCT04907487
Évaluation de l'Impact du Compressed Sensing Sur le Signal QSM
An observational study of MRI, 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 a maximum of four additional 25-minute sequences will be added. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MRI
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2021to 14 May 2025
- 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: Two groups of patients will be included as part of this research protocol: * Group I: Patients with MS * Group II: Patients with an indication to undergo a brain MRI and at low risk of inflammatory CNS pathology, age and gender matched with group I.
Who may be able to join
- For patients with MS:
- Patient over 18 years old
- Presenting MS defined according to McDonald's revised criteria for spatial and temporal clinical or radiological dissemination [16],
- Should benefit as part of the care of an MRI examination with or without injection of gadolinium
- Express consent to participate in the study
- Affiliate or beneficiary of a social security scheme
Show all 11Show fewer
- For patients with an indication to undergo a brain MRI and at low risk of inflammatory CNS disease:
- Patient over 18 years old
- Should benefit as part of the care of an MRI examination with or without injection of gadolinium
- Express consent to participate in the study
- Affiliate or beneficiary of a social security scheme
Who cannot join
- For patients with MS:
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
- For patients with an indication to undergo a brain MRI and at low risk of inflammatory CNS disease:
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
Show all 11Show fewer
- Patient with inflammatory and / or demyelinating pathology of the CNS
- Secondary exclusion criteria :
- Motion artefact not allowing interpretation of images
- Patient who did not perform one of the following sequences: 3D T1 TFE, 3D FLAIR (for MS patients), SWI QSM 1.0iso 8 echoes.
- Secondarily excluded patients will be replaced.
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 a maximum of four additional 25-minute sequences will be added.
MRI of routine care includes at least the following sequences:
- 3D T1 TFE (2 minutes)
- T2 TSE (2 minutes)
- 3D FLAIR (3 minutes)
The sequences added by the research lasting 25 minutes are:
- SWI QSM 1.0iso 8 echoes (10 minutes)
- SWI QSM 1.0iso 8 echoes CS 6 (7 minutes)
- SWI QSM 1.0iso 8 echoes CS 9 (5 minutes)
- SWI QSM 1.0iso 8 echoes CS 12 (3 minutes)
Read the detailed description
Patients who have agreed to participate in the study will complete the MRI protocol as part of routine care, to which a maximum of four additional 25-minute sequences will be added.
MRI of routine care includes at least the following sequences:
- 3D T1 TFE (2 minutes)
- T2 TSE (2 minutes)
- 3D FLAIR (3 minutes)
The sequences added by the research lasting 25 minutes are:
- SWI QSM 1.0iso 8 echoes (10 minutes)
- SWI QSM 1.0iso 8 echoes CS 6 (7 minutes)
- SWI QSM 1.0iso 8 echoes CS 9 (5 minutes)
- SWI QSM 1.0iso 8 echoes CS 12 (3 minutes)
- Conditions
- MRI
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
MRI of routine care includes at least the following sequences:
- 3D T1 TFE (2 minutes)
- T2 TSE (2 minutes)
- 3D FLAIR (3 minutes)
The sequences added by the research lasting 25 minutes are:
- SWI QSM 1.0iso 8 echoes (10 minutes)
- SWI QSM 1.0iso 8 echoes CS 6 (7 minutes)
- SWI QSM 1.0iso 8 echoes CS 9 (5 minutes)
- SWI QSM 1.0iso 8 echoes CS 12 (3 minutes)
| Study group | Role | What they receive |
|---|---|---|
| SEP | With Multiple Sclerosis as defined by McDonald's revised clinical or radiological spatial and temporal dissemination criteria Receives: Device: MRI | |
| NO SEP | For patients with an indication to undergo a brain MRI and at low risk of inflammatory CNS disease Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
concordance of QSM signal with and without compressed-sensing in white matter
concordance of QSM signal with and without compressed-sensing in white matter
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 posted28 May 2021
- Study start15 Dec 2021
- Primary completion14 May 2025
- Study completion14 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRIStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 82 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
- NCT04907487
- Sponsor's protocol ID
- JSY_2021_13
- Acronym
- CS-QSM
- Status last verified
- Dec 2025
- First submitted
- 25 May 2021
- Last updated
- 5 Jan 2026
- 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 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Évaluation de l'Impact du Compressed Sensing Sur le Signal QSM
- ClinicalTrials.gov ID
- NCT04907487
- Acronym / sponsor ID
- CS-QSM / JSY_2021_13
- Conditions
- MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 28 May 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 a maximum of four additional 25-minute sequences will be added.
MRI of routine care includes at least the following sequences:
- 3D T1 TFE (2 minutes)
- T2 TSE (2 minutes)
- 3D FLAIR (3 minutes)
The sequences added by the research lasting 25 minutes are:
- SWI QSM 1.0iso 8 echoes (10 minutes)
- SWI QSM 1.0iso 8 echoes CS 6 (7 minutes)
- SWI QSM 1.0iso 8 echoes CS 9 (5 minutes)
- SWI QSM 1.0iso 8 echoes CS 12 (3 minutes)
Detailed description
Patients who have agreed to participate in the study will complete the MRI protocol as part of routine care, to which a maximum of four additional 25-minute sequences will be added.
MRI of routine care includes at least the following sequences:
- 3D T1 TFE (2 minutes)
- T2 TSE (2 minutes)
- 3D FLAIR (3 minutes)
The sequences added by the research lasting 25 minutes are:
- SWI QSM 1.0iso 8 echoes (10 minutes)
- SWI QSM 1.0iso 8 echoes CS 6 (7 minutes)
- SWI QSM 1.0iso 8 echoes CS 9 (5 minutes)
- SWI QSM 1.0iso 8 echoes CS 12 (3 minutes)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SEP | – | Device: MRIWith Multiple Sclerosis as defined by McDonald's revised clinical or radiological spatial and temporal dissemination criteria |
| NO SEP | – | Device: MRIFor patients with an indication to undergo a brain MRI and at low risk of inflammatory CNS disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Two groups of patients will be included as part of this research protocol: * Group I: Patients with MS * Group II: Patients with an indication to undergo a brain MRI and at low risk of inflammatory CNS pathology, age and gender matched with group I.
Key inclusion criteria (11 listed)
- Patient over 18 years old
- Presenting MS defined according to McDonald's revised criteria for spatial and temporal clinical or radiological dissemination [16],
- Should benefit as part of the care of an MRI examination with or without injection of gadolinium
- Express consent to participate in the study
- Affiliate or beneficiary of a social security scheme
Key exclusion criteria (11 listed)
- For patients with MS:
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
- For patients with an indication to undergo a brain MRI and at low risk of inflammatory CNS disease:
- Patient benefiting from a legal protection measure
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 |
|---|---|---|
| MRIMRI of routine care includes at least the following sequences: * 3D T1 TFE (2 minutes) * T2 TSE (2 minutes) * 3D FLAIR (3 minutes) The sequences added by the research lasting 25 minutes are: * SWI QSM 1.0iso 8 echoes (10 minutes) * SWI QSM 1.0iso 8 echoes CS 6 (7 minutes) * SWI QSM 1.0iso 8 echoes CS 9 (5 minutes) * SWI QSM 1.0iso 8 echoes CS 12 (3 minutes) | Device | NO SEP, SEP |
Primary outcome
concordance of QSM signal with and without compressed-sensing in white matter
Time frame: 1 DAY
concordance of QSM signal with and without compressed-sensing in white matter
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.
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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 MRI, 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 11 inclusion and 11 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?
concordance of QSM signal with and without compressed-sensing in white matter (time frame: 1 DAY). 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.