Multiple SclerosisESPOIRNCT02896647
3D Phase Sensitive Inversion Recuperation MRI to Detect and Characterize Multiple Sclerosis Spinal Cord Lesions
An observational study of Multiple Sclerosis, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
This study aims to assess the interest of 3D Phase Sensitive Inversion Recuperation (PSIR)sequence in the MRI detection of spinal cord lesion. It will compare the sensitivity of this MRI sequence compared to the T1 and T2 sequences recommended in the assessment of neuraxis inflammatory diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2016to Sep 2018
- 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 scheduled for spinal cord MRI exploration for the assessment of a neuraxis inflammatory disease
Who may be able to join
- age ≥ 18 years old
- patients scheduled for spinal cord MRI exploration for the assessment of neuraxis inflammatory diseases
Who cannot join
- contraindication to MRI
- allergy to contrast media
- patient under legal protection
- no health insurance coverage
- patient's refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess the interest of 3D Phase Sensitive Inversion Recuperation (PSIR)sequence in the MRI detection of spinal cord lesion. It will compare the sensitivity of this MRI sequence compared to the T1 and T2 sequences recommended in the assessment of neuraxis inflammatory diseases.
- 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 spinal cord lesions
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start14 Dec 2016
- Primary completionSep 2018
- Study completionSep 2018
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Augustin LECLER, MD, Principal investigator, Fondation OPH A de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896647
- Sponsor's protocol ID
- ALR_2016_20
- Acronym
- ESPOIR
- Status last verified
- Sep 2021
- First submitted
- 7 Sep 2016
- Last updated
- 13 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Phase Sensitive Inversion Recuperation MRI to Detect and Characterize Multiple Sclerosis Spinal Cord Lesions
- ClinicalTrials.gov ID
- NCT02896647
- Acronym / sponsor ID
- ESPOIR / ALR_2016_20
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 14 Dec 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 12 Sep 2016 (estimated)
- 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 aims to assess the interest of 3D Phase Sensitive Inversion Recuperation (PSIR)sequence in the MRI detection of spinal cord lesion. It will compare the sensitivity of this MRI sequence compared to the T1 and T2 sequences recommended in the assessment of neuraxis inflammatory diseases.
Study design
- Observational model
- Other
- 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 scheduled for spinal cord MRI exploration for the assessment of a neuraxis inflammatory disease
Key inclusion criteria (2 listed)
- age ≥ 18 years old
- patients scheduled for spinal cord MRI exploration for the assessment of neuraxis inflammatory diseases
Key exclusion criteria (5 listed)
- contraindication to MRI
- allergy to contrast media
- patient under legal protection
- no health insurance coverage
- patient's refusal to participate in the study
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 spinal cord lesions
Time frame: baseline
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 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.
Augustin LECLER, MD principal investigator
Fondation OPH A de Rothschild
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 2 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 13 Sep 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 was stopped early. 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?
number of spinal cord 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 13 Sep 2021.