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Recruiting NCT07415759

Imaging of Electrical Properties by MRI: Investigation of Age-Related Changes

No phase Interventional Healthy Subjects

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnetic Resonance Imaging (MRI) examination.
Who it may be relevant to
Registry conditions: Healthy Subjects. Basic parameters: from 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The goal of this study is to build a database of personalized EP (Electrical Properties) maps (accounting for age, anatomical location, and tissue complexity), obtained via MRI, to improve electromagnetic safety assessments, especially in the context of MRI. The EP values derived from this study are expected to be more accurate than current literature values, leading to more realistic specific absorption rate (SAR) modeling and improved patient safety. To investigate age-related differences, the study will include three distinct age groups.

Interventions

  • Device Magnetic Resonance Imaging (MRI) examination
    MRI examination of the head and neck, and torso for the measurement of electrical properties

Primary outcome measures

  • Conductivity in S/m at the head level in subjects aged 6 to 12 years [Time frame: Baseline (J0)]
  • Conductivity in S/m at the head level in subjects aged 20 to 40 years [Time frame: Baseline (J0)]
  • Conductivity in S/m at the head level in subjects aged 70 and above [Time frame: Baseline (J0)]
  • Conductivity in S/m at the neck level in subjects aged 6 to 12 years [Time frame: Baseline (J0)]
  • Conductivity in S/m at the neck level in subjects aged 20 to 40 years [Time frame: Baseline (J0)]
  • Conductivity in S/m at the neck level in subjects aged 70 and above [Time frame: Baseline (J0)]
  • Conductivity in S/m at the torso level in subjects aged 6 to 12 years [Time frame: Baseline (J0)]
  • Conductivity in S/m at the torso level in subjects aged 20 to 40 years [Time frame: Baseline (J0)]
  • Conductivity in S/m at the torso level in subjects aged 70 and above [Time frame: Baseline (J0)]

Eligibility criteria

Inclusion criteria

  • Person aged between 6 and 12, 20 and 40 years or aged 70 years and above
  • Person affiliated with a social security scheme or beneficiary of such a scheme
  • Person, or parent/legal guardian in the case of minors, who has received full information about the organization of the study and has signed the informed consent form

Exclusion criteria

  • Contraindication to undergoing an MRI examination or the presence of an MRI-incompatible medical device
  • Person presenting a pathology or tissue damage in the examined areas that may affect the measured MRI parameters
  • Pregnant woman, woman in labor, or breastfeeding mother
  • Person deprived of liberty by judicial or administrative decision, or persons undergoing psychiatric care

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 2 centers
  • CHRU Nancy — Vandœuvre-lès-Nancy
  • Institut de Physique Biologique — Strasbourg

Identifiers

NCT: NCT07415759 · 2023-A01227-38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗