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Evaluation of Intra Organ Sodium Levels by Magnetic Resonance Imaging

NCT05215938 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2022-03-18

No results posted yet for this study

Summary

The investigators aim to implement an innovative imaging tool for detection of sodium level changes in-vivo with a clinical magnetic resonance (MR) scanner system. Conventionally, MR imaging (MRI) is performed with the use of proton imaging. Nevertheless, detection of other nuclei such as sodium (23Na) are possible with dedicated radio frequency sequences and radio frequency antennas tuned to the lower radio frequency of sodium. Non-invasive detection of sodium level changes has great potential as a precursor of organ deficiency and possible organ failure.

This project seeks to determine a robust method for detection and characterization of sodium levels with MRI. The sodium levels of the kidneys are known to change throughout the day. Therefore, an evaluation of the kidney circadian sodium level variation is performed.

In the proposed project, the investigators will scan two groups divided into two separate studies:

Healthy controls for optimization of imaging (n = 5, scanned twice) Healthy controls for comparison of circadian variation (n = 10, scanned triple on one day)

Sodium MRI could greatly improve the understanding and diagnostic capabilities of several medical conditions. If successful, the proposed project will serve as the groundwork for future clinical studies.

Conditions

  • Image, Body
  • Sodium Disorder

Interventions

DIAGNOSTIC_TEST

MRI examination

The magnetic resonance imaging session will be performed in a clinical 3T MRI scanner (GE healthcare). A commercial human intent non-diagnostic RF coil (PulseTeq) will be used for 23Na MRI. The scanner, coils and sequences are regularly used in research projects and validated for the same safety requirements as routinely used in the clinic. Nevertheless, the complete MRI session will be performed in research mode to use the advanced options (limits the usage to non-diagnostic purposes). Participants will be placed in a supine position with coils covering the area of interest (AOF). MRI examination will be performed by trained personnel.

Sponsors & Collaborators

  • GE Healthcare

    collaborator INDUSTRY

  • University of Aarhus

    lead OTHER

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-07
Primary Completion
2021-12-10
Completion
2021-12-10

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05215938 on ClinicalTrials.gov