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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-02

Study Completion Date

2021-04-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Magnetic Resonance Imaging Central Nervous System Brain Multiple Sclerosis Demyelinating Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MRI sequences

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.

Group Type OTHER

Additional MRI sequences

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No