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CompletedNCT03268239COGITEUpdated Jan 6, 2026

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

An interventional study of Additional MRI sequences in Magnetic Resonance Imaging, Central Nervous System and Brain, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Magnetic Resonance Imaging
  • Central Nervous System
  • Brain
  • Multiple Sclerosis
  • Demyelinating Diseases
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
180 participants (actual)

Study arms

  • Other
    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.

    Device: Additional MRI sequences

Interventions

  • DeviceAdditional 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.

05

What researchers measure

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.

    Time frame: Baseline

06

Study locations

1 site
  • Fondation Ophtalmologique A. de Rothschild
    Paris, France 75019, France
07

References and documents

Publications

  • 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. PubMed 36729811 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03268239
Lead sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Responsible party
Sponsor
First posted
Aug 31, 2017
Start date
Aug 2, 2017
Primary completion
Apr 26, 2021
Completion
Apr 26, 2021
Last update
Jan 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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