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

Multiple Sclerosis Clinical Trial

— COGITE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03268239
• Other study ID #: ALR_2017_11
• Status: Completed
• Phase: N/A
• Start date: August 2, 2017
• Est. completion date: April 26, 2021

Study information

• Verified date: September 2021
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 26, 2021
• Est. primary completion date: April 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Brain
• Central Nervous System
• Demyelinating Diseases
• Magnetic Resonance Imaging
• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Additional MRI sequences
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.

Locations

Country	Name	City	State
France	Fondation Ophtalmologique A. de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline