CompletedNot Applicable

Contrast-enhanced 3D T1-weighted Gradient-echo Versus Spin-echo 3 Tesla MR Sequences in the Detection of Active Multiple Sclerosis Lesions

France180 participantsStarted 2017-08-02

Plain-language 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 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of gadolinium-enhanced brain lesions

Timeframe: Baseline

Trial details

NCT IDNCT03268239

SponsorFondation Ophtalmologique Adolphe de Rothschild

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2021-04-26

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