Multiple SclerosisESPOIR1-5NCT04707144
Performance Evaluation of a 3D PSIR Sequence in MRI at 1.5T
An observational study of Multiple Sclerosis, run by Fondation Ophtalmologique Adolphe de Rothschild at 6 sites in France.
Trial summary
Inclusion visit (D0): verification of inclusion and non-inclusion criteria information and collection of consent standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), o 3D STIR sequence. 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?
- MRI 1.5 tesla
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 106 participants
- Where
- 6 sitesFrance
- Study dates
- 6 May 2021to 28 Jun 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: The study will be offered prospectively to patients presenting to the imaging department for a 1.5T MRI for bone marrow exploration, in the context of inflammatory involvement of the nevrax
Who may be able to join
- Patient over 18 years old
- To benefit from a medullary exploration planned by MRI 1.5T as part of a first evaluation or a re-evaluation of inflammatory involvement of the nevrax
- 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, parturient or breastfeeding woman
- Absolute or relative contraindication to MRI
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU DE Bordeaux
Bordeaux, 33000
Chu de Clermont-Ferrand
Clermont-Ferrand, 63000
Chu de Lille
Lille, 59000
CHU de LYON
Lyon, 69002
Hôpital privé des Peupliers
Paris, 75013
Fondation Ophtalmologique Adolphe de Rothschild (FOR)
Paris, 75019
About this study
Official title: Performance Evaluation of a 3D PSIR Sequence in MRI at 1.5T in the Detection and Characterization of Spinal Cord Injuries in Patients With Multiple Sclerosis
Inclusion visit (D0):
- verification of inclusion and non-inclusion criteria
- information and collection of consent
- standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), o 3D STIR sequence.
- 3D PSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 45 minutes (instead of 35 minutes).
- Conditions
- Multiple Sclerosis
- Being tested
- MRI 1.5 tesla
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI 1.5 teslaDevice
- standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), o 3D STIR sequence.
- 3D PSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 45 minutes (instead of 35 minutes)
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the number of spinal cord injuries detected with the set of standard sequences (T1, T2 and STIR) that are not detected with the 3D PSIR sequence
Measured: 1 DAY
Estimate the number of active lesions taking the contrast after injection of gadolinium, with the 3D PSIR sequence which is not detected in the set of standard sequences (T1, T2 and STIR)
Measured: 1 day
Compare the diagnostic confidence expressed by the radiologist for the detection of spinal cord injuries with the 3D PSIR sequence compared to the set of standard sequences (T1, T2 and STIR)
Measured: 1 DAY
Describe the quality of the images in terms of artifacts for each of the sequences used (T1, T2, STIR and PSIR)
Measured: 1 DAY
Measure the signal-to-noise ratio of each of the sequences used (T1, T2, STIR and PSIR)
Measured: 1 DAY
Measure the inter-observer agreement on the number of lesions detected with the 3D PSIR sequence
Measured: 1 DAY
Measure the intra-observer agreement on the number of lesions detected with the 3D PSIR 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 posted13 Jan 2021
- Study start6 May 2021
- Primary completion6 Jun 2023
- Study completion28 Jun 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
- 106 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
- NCT04707144
- Sponsor's protocol ID
- ALR_2020_40
- Acronym
- ESPOIR1-5
- Status last verified
- Dec 2023
- First submitted
- 11 Jan 2021
- Last updated
- 13 Dec 2023
- 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 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of a 3D PSIR Sequence in MRI at 1.5T in the Detection and Characterization of Spinal Cord Injuries in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04707144
- Acronym / sponsor ID
- ESPOIR1-5 / ALR_2020_40
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 6 May 2021 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 13 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.
Inclusion visit (D0):
- verification of inclusion and non-inclusion criteria
- information and collection of consent
- standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), o 3D STIR sequence.
- 3D PSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 45 minutes (instead of 35 minutes).
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
- The study will be offered prospectively to patients presenting to the imaging department for a 1.5T MRI for bone marrow exploration, in the context of inflammatory involvement of the nevrax
Key inclusion criteria (4 listed)
- Patient over 18 years old
- To benefit from a medullary exploration planned by MRI 1.5T as part of a first evaluation or a re-evaluation of inflammatory involvement of the nevrax
- Express consent to participate in the study
- Affiliate or beneficiary of a social security scheme
Key exclusion criteria (3 listed)
- Patient benefiting from a legal protection measure
- Pregnant, parturient or breastfeeding woman
- Absolute or relative contraindication to MRI
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 |
|---|---|---|
| MRI 1.5 tesla* standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), o 3D STIR sequence. * 3D PSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 45 minutes (instead of 35 minutes) | Device | – |
Primary outcome
Estimate the number of spinal cord injuries detected with the set of standard sequences (T1, T2 and STIR) that are not detected with the 3D PSIR sequence
Time frame: 1 DAY
Estimate the number of active lesions taking the contrast after injection of gadolinium, with the 3D PSIR sequence which is not detected in the set of standard sequences (T1, T2 and STIR)
Time frame: 1 day
Compare the diagnostic confidence expressed by the radiologist for the detection of spinal cord injuries with the 3D PSIR sequence compared to the set of standard sequences (T1, T2 and STIR)
Time frame: 1 DAY
Describe the quality of the images in terms of artifacts for each of the sequences used (T1, T2, STIR and PSIR)
Time frame: 1 DAY
Measure the signal-to-noise ratio of each of the sequences used (T1, T2, STIR and PSIR)
Time frame: 1 DAY
Measure the inter-observer agreement on the number of lesions detected with the 3D PSIR sequence
Time frame: 1 DAY
Measure the intra-observer agreement on the number of lesions detected with the 3D PSIR 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 13 Dec 2023.
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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.
6 sites 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 6 sites 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 4 inclusion and 3 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 13 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 6 sites 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?
Estimate the number of spinal cord injuries detected with the set of standard sequences (T1, T2 and STIR) that are not detected with the 3D PSIR sequence (time frame: 1 DAY). The study lists 7 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 13 Dec 2023.