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

NCT03268239 | Completed

• 1 other identifier: ALR_2017_11
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Device: Additional MRI sequences

Interventions

Additional MRI sequences DEVICE

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.

MRI sequences

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique A. de Rothschild

Paris, France, 75019, France

Location

Related Publications (1)

• 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.

  PMID: 36729811 RESULT

MeSH Terms

Conditions

Multiple Sclerosis; Demyelinating Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: August 31, 2017
• Study Start: August 2, 2017
• Primary Completion: April 26, 2021
• Study Completion: April 26, 2021
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

FR (1)