Contrast-enhanced 3D T1-weighted Gradient-echo Versus Spin-echo 3 Tesla MR Sequences in the Detection of Active Multiple Sclerosis Lesions (COGITE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03268239|
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : August 19, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Magnetic Resonance Imaging Central Nervous System Brain Multiple Sclerosis Demyelinating Diseases||Device: Additional MRI sequences||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Contrast-enhanced 3D T1-weighted Gradient-echo Versus Spin-echo 3 Tesla MR Sequences in the Detection of Active Multiple Sclerosis Lesions|
|Actual Study Start Date :||August 2, 2017|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
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.
Device: Additional MRI sequences
Due to the participation in the study, the following sequences are added to the imaging protocol:
Sequences will be performed in a random order to avoid the bias induced by different time intervals between injection and acquisition.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268239
|Contact: Laurence Salomon, MD PhD||0148036431 ext +firstname.lastname@example.org|
|Contact: Augustin Lecler, MDemail@example.com|