White Matter HyperintensityERESINCT04465448
Evaluation of the Reproducibility of the Measurement of the QSM Signal (Quantitative Susceptibility Mapping)
An observational study of White Matter Hyperintensity and Multiple Sclerosis, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Many central nervous system pathologies have an inflammatory component, often associated with an accumulation of disability and more severe tissue damage. In multiple sclerosis, the inflammatory process is in part characterized by the activation of microglia, an entity of the innate inflammatory system, as well as a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- White Matter Hyperintensity, Multiple Sclerosis
- What is being tested?
- MRI
- Type of treatment
- Injection or infusion
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 17 Dec 2020to 16 Jun 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participation in the study will be offered to patients with MS (the primary indication for which QSM is studied) as well as to healthy volunteers among staff.
Who may be able to join
- Subject over 18 years old
- Consent to participate in the study
- Beneficiary of a social protection scheme
- Healthy volunteers: Consent to be informed if an unexpected anomaly is revealed by the imagery.
- Patients: With MS defined according to McDonald's revised criteria for spatial dissemination and temporal or clinical or radiological temporal dissemination and who should benefit from MRI in the imaging department
Who cannot join
- Absolute contraindication to 3T MRI
- Realization of an injected MRI (gadolinium) in the previous year
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
- For healthy volunteers: History of neurological pathology or neurological pathology in progress
Trial locations and contacts
1 site in 1 country.
About this study
Many central nervous system pathologies have an inflammatory component, often associated with an accumulation of disability and more severe tissue damage.
In multiple sclerosis, the inflammatory process is in part characterized by the activation of microglia, an entity of the innate inflammatory system, as well as a breakdown of the blood-brain barrier. During inflammation, activated microglia may contain high levels of iron, characterizing its activated state.
Read the detailed description
Several MRI imaging tools are known to be highly sensitive to tissue iron content and have become the method of choice to study brain iron, including in a pathological context such as multiple sclerosis.
Quantitative magnetic susceptibility mapping (QSM) is an emerging technique to access non-invasively the iron content in brain tissue. For some years this technique has been used in MS to characterize white matter lesions. Changes in the QSM value of the lesions have made it possible to describe lesions surrounded by an iron ring. Susceptibility MRI has also been proposed to highlight lesions according to their chronology.
The study of reproducibility is of particular importance when using QSM in longitudinal studies or in therapeutic trials. A better understanding of intra- and inter-subject variation in QSM measurements may also allow a more accurate estimate of the number of subjects needed to detect changes in studies. In order to be widely applied to various pathologies, it is therefore necessary to evaluate its reproducibility by estimating the intra- and inter-subject variability for future dissemination in clinical and pharmaceutical studies.
In this project, the invstigators propose to study the reproducibility of QSM acquisition.
- Conditions
- White Matter Hyperintensity, Multiple Sclerosis
- Being tested
- 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.
MRIOther
Those included will perform an MRI without injection to obtain the QSM then they will exit the machine and reinstall themselves there to perform the second measurement. They will then change the MRI machine to perform a third measurement
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Not described Receives: Other: MRI | |
| group case | Not described Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
QSM signal difference at two acquisition times in white matter, on an individual scale
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start17 Dec 2020
- Primary completion16 Jun 2022
- Study completion16 Jun 2022
Why it stopped: MRI issue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Matter HyperintensityStudies 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
- 18 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
- NCT04465448
- Sponsor's protocol ID
- JSY_2020_25
- Acronym
- ERESI
- Status last verified
- Dec 2022
- First submitted
- 7 Jul 2020
- Last updated
- 18 Dec 2023
- 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 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Reproducibility of the Measurement of the QSM Signal (Quantitative Susceptibility Mapping)
- ClinicalTrials.gov ID
- NCT04465448
- Acronym / sponsor ID
- ERESI / JSY_2020_25
- Conditions
- White Matter Hyperintensity, Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: MRI issue.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 10 Jul 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.
Many central nervous system pathologies have an inflammatory component, often associated with an accumulation of disability and more severe tissue damage.
In multiple sclerosis, the inflammatory process is in part characterized by the activation of microglia, an entity of the innate inflammatory system, as well as a breakdown of the blood-brain barrier. During inflammation, activated microglia may contain high levels of iron, characterizing its activated state.
Detailed description
Several MRI imaging tools are known to be highly sensitive to tissue iron content and have become the method of choice to study brain iron, including in a pathological context such as multiple sclerosis.
Quantitative magnetic susceptibility mapping (QSM) is an emerging technique to access non-invasively the iron content in brain tissue. For some years this technique has been used in MS to characterize white matter lesions. Changes in the QSM value of the lesions have made it possible to describe lesions surrounded by an iron ring. Susceptibility MRI has also been proposed to highlight lesions according to their chronology.
The study of reproducibility is of particular importance when using QSM in longitudinal studies or in therapeutic trials. A better understanding of intra- and inter-subject variation in QSM measurements may also allow a more accurate estimate of the number of subjects needed to detect changes in studies. In order to be widely applied to various pathologies, it is therefore necessary to evaluate its reproducibility by estimating the intra- and inter-subject variability for future dissemination in clinical and pharmaceutical studies.
In this project, the invstigators propose to study the reproducibility of QSM acquisition.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | – | Other: MRI |
| group case | – | Other: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participation in the study will be offered to patients with MS (the primary indication for which QSM is studied) as well as to healthy volunteers among staff.
Key inclusion criteria (5 listed)
- Subject over 18 years old
- Consent to participate in the study
- Beneficiary of a social protection scheme
- Healthy volunteers: Consent to be informed if an unexpected anomaly is revealed by the imagery.
- Patients: With MS defined according to McDonald's revised criteria for spatial dissemination and temporal or clinical or radiological temporal dissemination and who should benefit from MRI in the imaging department
Key exclusion criteria (5 listed)
- Absolute contraindication to 3T MRI
- Realization of an injected MRI (gadolinium) in the previous year
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
- For healthy volunteers: History of neurological pathology or neurological pathology in progress
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 |
|---|---|---|
| MRIThose included will perform an MRI without injection to obtain the QSM then they will exit the machine and reinstall themselves there to perform the second measurement. They will then change the MRI machine to perform a third measurement | Other | group case, healthy volunteers |
Primary outcome
QSM signal difference at two acquisition times in white matter, on an individual scale
Time frame: baseline
Results and safety
The study was stopped early (reason given: MRI issue.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- 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 White Matter Hyperintensity 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 18 Dec 2023. 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 was stopped early (reason given: MRI issue.). Results are not available in the source record.
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?
QSM signal difference at two acquisition times in white matter, on an individual scale (time frame: baseline). 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 18 Dec 2023.