Multiple SclerosisFLAIR-SEPNCT03108573
Improved Detection of Multiple Sclerosis Plaques in Inversion Recovery by Optimization of Sequence Parameters
An observational study of Multiple Sclerosis, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
This study evaluates different optimized MRI sequences for the detection of brain lesions in patients with multiple sclerosis in comparison with the recommended FLAIR sequence Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 12 Dec 2012to 31 Jul 2013
- 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 a definite diagnosis of multiple sclerosis, with a follow-up MRI
Who may be able to join
- relapsing remitting multiple sclerosis
- MRI required
Who cannot join
- MRI contraindication
About this study
This study evaluates different optimized MRI sequences for the detection of brain lesions in patients with multiple sclerosis in comparison with the recommended FLAIR sequence
Read the detailed description
MRI is a tool of choice for detecting demyelinating lesions in Multiple Sclerosis (MS) disease. On a consensual basis, the detection of those lesions in done on FLAIR (FLuid Attenuated Inversion Recovery) sequences, weighted T2 with cancelling of fluid signal, leading to a much better contrast between the lesion and the environment. The environment is displayed as a iso-signal for the surrounding healthy brain's white matter and as a hypo-signal for the fluids. Keys parameters indicative of the sequence's contrast are the echo time, the reversal time, and the repetition time, wich seems to be crucial to detect the lesions, according to relatively discordant results of publications using different technologies of FLAIR. Although 3D FLAIR sequences play an essential role for diagnosis and evaluation (evolution under treatment, prognosis) of demyelinating pathologies there is no consensus on parameters used on routine basis.
The aim of the trial is to discover the optimal combination of theses parameters so as to well detect the lesions.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of detectable lesions
quantification of lesions on each sequence
Measured: baseline
Secondary outcomes (1)
localisation of lesions
proportion of lesions localised in cerebellum or brainstem, on each sequence
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start12 Dec 2012
- Primary completion31 Jul 2013
- Study completion31 Jul 2013
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.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 27 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
- NCT03108573
- Sponsor's protocol ID
- SC/DM_JSY_2012-3
- Acronym
- FLAIR-SEP
- Status last verified
- Mar 2017
- First submitted
- 16 Mar 2017
- Last updated
- 11 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Detection of Multiple Sclerosis Plaques in Inversion Recovery by Optimization of Sequence Parameters
- ClinicalTrials.gov ID
- NCT03108573
- Acronym / sponsor ID
- FLAIR-SEP / SC/DM_JSY_2012-3
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 12 Dec 2012 (actual)
- Primary completion
- 31 Jul 2013 (actual)
- Study completion
- 31 Jul 2013 (actual)
- First posted
- 11 Apr 2017 (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.
This study evaluates different optimized MRI sequences for the detection of brain lesions in patients with multiple sclerosis in comparison with the recommended FLAIR sequence
Detailed description
MRI is a tool of choice for detecting demyelinating lesions in Multiple Sclerosis (MS) disease. On a consensual basis, the detection of those lesions in done on FLAIR (FLuid Attenuated Inversion Recovery) sequences, weighted T2 with cancelling of fluid signal, leading to a much better contrast between the lesion and the environment. The environment is displayed as a iso-signal for the surrounding healthy brain's white matter and as a hypo-signal for the fluids. Keys parameters indicative of the sequence's contrast are the echo time, the reversal time, and the repetition time, wich seems to be crucial to detect the lesions, according to relatively discordant results of publications using different technologies of FLAIR. Although 3D FLAIR sequences play an essential role for diagnosis and evaluation (evolution under treatment, prognosis) of demyelinating pathologies there is no consensus on parameters used on routine basis.
The aim of the trial is to discover the optimal combination of theses parameters so as to well detect the lesions.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with a definite diagnosis of multiple sclerosis, with a follow-up MRI
Key inclusion criteria (2 listed)
- relapsing remitting multiple sclerosis
- MRI required
Key exclusion criteria (1 listed)
- MRI contraindication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of detectable lesions
Time frame: baseline
quantification of lesions on each sequence
1 secondary outcome
localisation of lesions
Time frame: baseline
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 11 Apr 2017.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, 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 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 11 Apr 2017. 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?
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?
Number of detectable lesions (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 11 Apr 2017.