Evaluation of Intra Organ Sodium Levels by Magnetic Resonance Imaging

NCT05215938 | Completed DMC

• 1 other identifier: 1-10-72-210-21
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

MRI; Sodium imaging; B1 field correction; Kidney circadian sodium level variation; Multi-organ

Outcome Measures

Primary Outcomes (1)

• Evaluation of intra organ sodium levels by magnetic resonance imaging

  The overall aim of this study is to implement and validate an imaging protocol for detection of sodium level changes in-vivo and determine circadian sodium level variations. This will be carried out in two separate studies.

  6 months

Secondary Outcomes (2)

• Study I: Multi-organ sodium imaging with B1 field correction

  6 months

• Study II: Circadian sodium level variation in the kidney measured with MRI

  6 months

Study Arms (2)

Study I: Multi-organ sodium imaging with B1 field correction

The scan will be performed in four area of interests (AOFs) to acquire sodium level signal form the thigh, heart, kidneys, and brain. Between each AOF the sodium receive coil will be moved to cover the specific organ. Determination of the sodium imaging method robustness is performed with a series of MRI sequences. The scans at the four AOFs are repeated to evaluate repeatability. The scan time with repositioning of coils is approximately 15 min per station (total scan time 2 hours). If needed the participants are able to have a break between scan stations.

Diagnostic Test: MRI examination

Study II: Circadian sodium level variation in the kidney measured with MRI

Participation requires one full day at the MR Centre. MRI scans will be performed three times at the same day within the following time periods: 6.30-8.00 am. (before breakfast), 12.30-14-00 pm. (after lunch) and 21.00-22.00 pm. (after dinner). The scan time is expected to be 30-40 min at each scan (three scans are performed on one examination day), which requires a total scan time \~1½ hours. Participants are not allowed to perform excessive physical exercise the day before and during the study day. Lighter physical exercise as walking, biking etc. is accepted. Alcohol consuming is not allowed the day before and during the study day. The participants can drink and eat as usual, but all fluid intake and urinations shall be documented in a liquid urination schedule. Blood pressure will be measured at each scan session and urine samples are collected just after each scan session to assess the osmolarity.

Diagnostic Test: MRI examination

Interventions

MRI examination DIAGNOSTIC_TEST

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.

Study I: Multi-organ sodium imaging with B1 field correction; Study II: Circadian sodium level variation in the kidney measured with MRI

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy men and women in the ages of 20 to 60.

You may qualify if:

• Participants are eligible if they can provide informed consent and meet the following criteria:
• Healthy men and women aged 20-60 years.
• Five participants of each gender are required in study II, whereto, gender is not of importance in study I.
• Healthy is defined as no use of medicine besides from contraceptives and vitamins.

You may not qualify if:

• The participants are not eligible if they fulfill any of the following criteria:
• Persons with circumference including arms \> 160 cm. (MR scanner bore size)
• Pregnant women are not allowed to volunteer.

Sponsors & Collaborators

• University of Aarhus: lead
• GE Healthcare: collaborator

Study Sites (1)

MR Research Centre

Aarhus N, 8200, Denmark

Location

Related Publications (2)

• Vaeggemose M, Schulte RF, Hansen ESS, Miller JJ, Rasmussen CW, Pilgrim-Morris JH, Stewart NJ, Collier GJ, Wild JM, Laustsen C. A Framework for Predicting X-Nuclei Transmitter Gain Using 1H Signal. Tomography. 2023 Aug 24;9(5):1603-1616. doi: 10.3390/tomography9050128.

  PMID: 37736981 DERIVED

• Rasmussen CW, Bogh N, Ringgaard S, Birn H, Vaeggemose M, Schulte RF, Laustsen C. Daytime Variation in Kidney Perfusion, Oxygenation, and Sodium Concentration Assessed by Multiparametric MRI in Healthy Volunteers. J Magn Reson Imaging. 2024 May;59(5):1603-1611. doi: 10.1002/jmri.28983. Epub 2023 Sep 1.

  PMID: 37656067 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples to measure: Urinary albumin/creatinine excretion ratio, Na+, K+ and osmolarity. The laboratory analyses will be performed within seven days of collection and all urine samples will be eliminated afterwards.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 31, 2022
• Study Start: July 7, 2021
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2021
• Last Updated: March 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)