Magnetic Resonance ImagingCOGITENCT03268239
Contrast-enhanced 3D T1-weighted Gradient-echo Versus Spin-echo 3 Tesla MR Sequences in the Detection of Active Multiple Sclerosis Lesions
A study testing Additional MRI sequences in people with Magnetic Resonance Imaging and Central Nervous System, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Gadolinium-enhanced magnetic resonance imaging (MRI) is currently the imaging gold standard to detect active inflammatory lesions in multiple sclerosis (MS) patients. The sensitivity of enhanced MRI to detect active lesions may vary according to the acquisition strategy used (e.g., delay between injection and image… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Magnetic Resonance Imaging, Central Nervous System, Brain
- What is being tested?
- Additional MRI sequences
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 2 Aug 2017to 26 Apr 2021
- Phase
- Interventional
- 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
Who may be able to join
- Equal or more than 18 years of age
- Able to provide written informed consent.
- Known central nervous system inflammatory disease
- Magnetic Resonance exam needed for evaluation after a clinical event in the last 3 weeks
Who cannot join
- Current treatment with dimethylfumarate (Tecfidera®), natalizumab (Tysabri®) or fingolimod (Gilenya®)
- Contraindications either to 3 Tesla Magnetic Resonance Imaging (e.g. certain metallic and electronic implants, claustrophobia) or IV gadolinium contrast (allergy, pregnancy, breast-feeding, renal insufficiency).
Trial locations and contacts
1 site in 1 country.
About this study
Gadolinium-enhanced magnetic resonance imaging (MRI) is currently the imaging gold standard to detect active inflammatory lesions in multiple sclerosis (MS) patients. The sensitivity of enhanced MRI to detect active lesions may vary according to the acquisition strategy used (e.g., delay between injection and image acquisition, contrast dose, field strength, and frequency of MRI sampling). Selection of the most appropriate T1-weighted sequence after contrast injection may also influence sensitivity. Several clinical studies performed at 1.5 Tesla have shown that conventional 2D spin-echo (SE) sequences perform better than gradient recalled-echo (GRE) sequences for depicting active MS lesions after gadolinium injection. As relates to MS, 3.0 Tesla systems offer some advantages over lower field strengths, such as higher detection rates for T2 and gadolinium-enhancing brain lesions, an important capability for diagnosing and monitoring MS patients. Recent studies have shown that at 3 Tesla, 3D GRE or 3D fast SE sequences provide higher detection rates for gadolinium-enhancing MS lesions, especially smaller ones, than standard 2D SE, and better suppress artefacts related to vascular pulsation. However, the comparison of the performance of 3D GRE versus 3D SE sequences has not been investigated yet.
Objectives To compare the sensitivity of enhancing multiple sclerosis (MS) lesions in gadolinium-enhanced 3D T1-weighted gradient-echo (GRE) and turbo-spin-echo (TSE) sequences.
- Conditions
- Magnetic Resonance Imaging, Central Nervous System, Brain, Multiple Sclerosis, Demyelinating Diseases
- Being tested
- Additional MRI sequences
- Medical subject headings
- Multiple Sclerosis, Demyelinating Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional MRI sequencesDevice
Due to the participation in the study, the following sequences are added to the imaging protocol:
- 3D T1 GRE after injection (Gradient-Recalled Echo)
- 3D T1 TSE before injection (Turbo Spin Echo)
- 3D fGATIR PSIR after injection (fast Gray Matter Acquisition T1 Inversion Recovery Phase-Sensitive Inversion Recovery)
Sequences will be performed in a random order to avoid the bias induced by different time intervals between injection and acquisition.
| Study group | Role | What they receive |
|---|---|---|
| MRI sequences | Other | There will be only one arm of patients with central nervous system inflammatory disease.
Each patient will be its own control. The usual and additional MRI sequences will be performed in all patients and the number of lesions obtained in usual sequences and additional sequences will be compared in the same patient. Receives: Device: Additional MRI sequences |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of gadolinium-enhanced brain lesions
Number of gadolinium-enhanced brain lesions depicted on a 3D T1 Turbo Spin Echo sequence compared to those depicted on the 3D T1 Gradient-Recalled Echo 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 posted31 Aug 2017
- Study start2 Aug 2017
- Primary completion26 Apr 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Magnetic Resonance ImagingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 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
- NCT03268239
- Sponsor's protocol ID
- ALR_2017_11
- Acronym
- COGITE
- Status last verified
- Jan 2026
- First submitted
- 28 Aug 2017
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
de Panafieu A, Lecler A, Goujon A, Krystal S, Gueguen A, Sadik JC, Savatovsky J, Duron L. Contrast-Enhanced 3D Spin Echo T1-Weighted Sequence Outperforms 3D Gradient Echo T1-Weighted Sequence for the Detection of Multiple Sclerosis Lesions on 3.0 T Brain MRI. Invest Radiol. 2023 May 1;58(5):314-319. doi: 10.1097/RLI.0000000000000937. Epub 2022 Dec 8.
PubMed 36729811
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-enhanced 3D T1-weighted Gradient-echo Versus Spin-echo 3 Tesla MR Sequences in the Detection of Active Multiple Sclerosis Lesions
- ClinicalTrials.gov ID
- NCT03268239
- Acronym / sponsor ID
- COGITE / ALR_2017_11
- Conditions
- Magnetic Resonance Imaging, Central Nervous System, Brain, Multiple Sclerosis, Demyelinating Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 31 Aug 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.
Gadolinium-enhanced magnetic resonance imaging (MRI) is currently the imaging gold standard to detect active inflammatory lesions in multiple sclerosis (MS) patients. The sensitivity of enhanced MRI to detect active lesions may vary according to the acquisition strategy used (e.g., delay between injection and image acquisition, contrast dose, field strength, and frequency of MRI sampling). Selection of the most appropriate T1-weighted sequence after contrast injection may also influence sensitivity. Several clinical studies performed at 1.5 Tesla have shown that conventional 2D spin-echo (SE) sequences perform better than gradient recalled-echo (GRE) sequences for depicting active MS lesions after gadolinium injection. As relates to MS, 3.0 Tesla systems offer some advantages over lower field strengths, such as higher detection rates for T2 and gadolinium-enhancing brain lesions, an important capability for diagnosing and monitoring MS patients. Recent studies have shown that at 3 Tesla, 3D GRE or 3D fast SE sequences provide higher detection rates for gadolinium-enhancing MS lesions, especially smaller ones, than standard 2D SE, and better suppress artefacts related to vascular pulsation. However, the comparison of the performance of 3D GRE versus 3D SE sequences has not been investigated yet.
Objectives To compare the sensitivity of enhancing multiple sclerosis (MS) lesions in gadolinium-enhanced 3D T1-weighted gradient-echo (GRE) and turbo-spin-echo (TSE) sequences.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI sequences | Other | Device: Additional MRI sequencesThere will be only one arm of patients with central nervous system inflammatory disease. Each patient will be its own control. The usual and additional MRI sequences will be performed in all patients and the number of lesions obtained in usual sequences and additional sequences will be compared in the same patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Equal or more than 18 years of age
- Able to provide written informed consent.
- Known central nervous system inflammatory disease
- Magnetic Resonance exam needed for evaluation after a clinical event in the last 3 weeks
Key exclusion criteria (2 listed)
- Current treatment with dimethylfumarate (Tecfidera®), natalizumab (Tysabri®) or fingolimod (Gilenya®)
- Contraindications either to 3 Tesla Magnetic Resonance Imaging (e.g. certain metallic and electronic implants, claustrophobia) or IV gadolinium contrast (allergy, pregnancy, breast-feeding, renal insufficiency).
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 |
|---|---|---|
| Additional MRI sequencesDue to the participation in the study, the following sequences are added to the imaging protocol: * 3D T1 GRE after injection (Gradient-Recalled Echo) * 3D T1 TSE before injection (Turbo Spin Echo) * 3D fGATIR PSIR after injection (fast Gray Matter Acquisition T1 Inversion Recovery Phase-Sensitive Inversion Recovery) Sequences will be performed in a random order to avoid the bias induced by different time intervals between injection and acquisition. | Device | MRI sequences |
Primary outcome
Number of gadolinium-enhanced brain lesions
Time frame: Baseline
Number of gadolinium-enhanced brain lesions depicted on a 3D T1 Turbo Spin Echo sequence compared to those depicted on the 3D T1 Gradient-Recalled Echo sequence.
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 6 Jan 2026.
- Results publication: PubMed 36729811de Panafieu A, Lecler A, Goujon A, Krystal S, Gueguen A, Sadik JC, Savatovsky J, Duron L. Contrast-Enhanced 3D Spin Echo T1-Weighted Sequence Outperforms 3D Gradient Echo T1-Weighted Sequence for the Detection of Multiple Sclerosis Lesions on 3.0 T Brain MRI. Invest Radiol. 2023 May 1;58(5):314-319. doi: 10.1097/RLI.0000000000000937. Epub 2022 Dec 8.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Additional MRI sequences in people with Magnetic Resonance Imaging and Central Nervous System, 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 4 inclusion and 2 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 6 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?
Number of gadolinium-enhanced brain lesions (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03268239, which also lists 1 linked publication.
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 6 Jan 2026.