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NCT Number: NCT05218460

Evaluation of Methodological and Technical DEvelopmeNts to Improve the Quality and Comfort of Magnetic Resonance Imaging Exam on Voluntary Subjects

The EDEN study will make it possible to evaluate one or more development phases (from design to validation through optimization) of a method or a technique on voluntary subjects, in normal or pathological condition.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for all subjects :

  • to be over 18 year-old,
  • to be enrolled in a social security plan,
  • to have underwent a pre-inclusion medical examination,
  • to give a written consent.

Inclusion criteria

for volunteers with pathology :

  • person with a pathology characterized by a functional and / or morphological alteration that may have an impact on the data collected (images, physiological signals, ...).

Exclusion criteria

for all subjects :

  • any contraindication to MR examination (active medical device, ferromagnetic foreign body, pregnancy, morbid obesity, claustrophobia, … ),
  • subject under a measure of legal protection,
  • Person who refuses to be informed by a doctor in th event of a fortuitus discovery of an abnormality on the MRI examination requiring additionnal examinations or specific treatment.

Treatment and study plan

MRI examination

Device

All subjects (healthy and pathological subjects) will have an MRI examination with a component of the MRI system under development.

Primary outcomes

  1. Image quality based on standard imaging quality criteria

    Time frame: 6 months after the last inclusion

    The image quality will be appreciated visually at least by a radiologist or a researcher.

  2. Signal quality based on standard signal quality criteria

    Time frame: 6 months after the last inclusion

    The signal quality will be appreciated visually at least by a radiologist or a researcher.

Secondary outcomes

  1. Comparison of the Signal to Noise Ratio obtained by the component of the MRI system under development and the reference situation.

    Time frame: 6 months after the last inclusion

    ignal to Noise Ratio will be measured in arbitrary units.

  2. Comparison of the Contrast to Noise Ratio obtained by the component of the MRI system under development and the reference situation.

    Time frame: 6 months after the last inclusion

    Contrast to Noise Ratio will be measured in arbitrary units.

  3. Comparison of blurring and artefacts obtained by the component of the MRI system under development and the reference situation.

    Time frame: 6 months after the last inclusion

    Absence of blurring and artefacts will be assessed by at least one radiologist according to an ordinal scale (1 to 5 ; 1 is the worst score and 5 is the better score).

Study contacts

Contact information is provided by the study sponsor or research team.

Damien MANDRY, MD, PhD

CONTACT

[email protected]

+33383154202

Gabriela HOSSU, PhD

CONTACT

[email protected]

+33383155096

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: EDEN

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 1, 2022
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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