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

January 2, 2026 updated by: Fondation Ophtalmologique Adolphe de Rothschild

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • France
      • Paris, France, France, 75019
        • Fondation Ophtalmologique A. De Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2017

Primary Completion (Actual)

April 26, 2021

Study Completion (Actual)

April 26, 2021

Study Registration Dates

First Submitted

August 28, 2017

First Submitted That Met QC Criteria

August 30, 2017

First Posted (Actual)

August 31, 2017

Study Record Updates

Last Update Posted (Estimated)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALR_2017_11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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