Image, BodyNCT05215938
Evaluation of Intra Organ Sodium Levels by Magnetic Resonance Imaging
An observational study of Image, Body and Sodium Disorder, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Image, Body, Sodium Disorder
- What is being tested?
- MRI examination
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Jul 2021to 10 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Adult
Study population: Healthy men and women in the ages of 20 to 60.
Who may be able to join
- 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.
Who cannot join
- The participants are not eligible if they fulfill any of the following criteria:
- Exclusion criteria for the MRI are contraindication to MRI such as claustrophobia or the presence of a pacemaker or other implanted metallic device.
- Persons with circumference including arms > 160 cm. (MR scanner bore size)
- Pregnant women are not allowed to volunteer.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
Background
Magnetic resonance imaging is considered the gold standard medical imaging modality for soft tissue characterization. The basic approach of MRI is acquiring resonance signal of proton (1H) spins which is abundant in soft tissue. In general, MRI scanner radio frequency antennas (RF coils) only tuned to transmit and receive at the frequency of hydrogen for proton imaging; however, it is possible to transmit and receive on other frequencies to create resonance images of different molecules.
Acquisition of other nuclei is performed with MR spectroscopy (MRS) and spectroscopic imaging (MRSI). For in vivo applications, common MR-active nuclei are protons (1H), phosphorus (31P), carbon (13C), sodium (23Na), and xenon (129Xe). Protons are the most common due to their high gyromagnetic ratio and natural abundance in the human body. Sodium is the second most abundant of the magnetic resonance sensitive nuclei.
Sodium MRI allows non-invasive examinations of intra-organ sodium concentrations and handling in vivo. These are coupled to electrophysiological and metabolic processes crucial to life. The methods have been thoroughly investigated in laboratory settings but has never made the transition to the clinic due to the inherently low signal to noise of sodium MRI [1]. Imaging is often challenged by a gyromagnetic ratio of about 1/4th of proton making the signal-to-noise ratio (SNR) of 23Na MRI about 6000 times lower than that of proton MRI [2]. Nevertheless, recent years has seen a renewed interest in sodium MRI due to major technical advances of MRI scanner systems and receive coils [1].
In vivo measurements of sodium levels are of special interest for determination of the energy dependent Na+/K+-ATPase (the sodium-potassium pump) - an important physiological transport process of healthy cells [3]-[5]. A transport process which is affected in many clinical conditions involving tissue injury, edema, or necrosis resulting in an increase of total sodium level [6].
Recent studies of sodium levels in healthy subjects have shown circadian variation of several physiological processes e.g. urine output, blood pressure and kidney function [7], [8]. A decrease in sodium excretion at night is showed in humans [7] and renal handling of sodium level is reported to follow circadian variations in mice [9]. It is therefore important to evaluate sodium imaging robustness, possible bias due to circadian variation, and a possible effect of disruption in the circadian rhythms leading to development or progression of certain diseases.
This study aims to evaluate the circadian rhythm in healthy human kidneys. If a circadian change of sodium levels is proven, further investigations of sodium level in diseases such as kidney disease can be developed. The results from this study will provide valuable information for assessment of sodium levels in humans and will contribute to the diagnostic process of multiple disease.
Aim
Increased recognition of the circadian variation is needed as it may result in a foundation for improved understanding of disease processes in several clinical conditions.
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:
Study I - Evaluation of sodium levels in thigh, heart, kidney, and brain:
The aim of the study is to evaluate sodium levels in thigh, heart, kidney, and brain with the use of magnetic resonance imaging in healthy human subjects.
This initial study will determine the robustness of the sodium specific imaging method in determination of human sodium levels in different MR challenging conditions and organs. The study will provide the needed information to create an optimal scanning protocol for sodium imaging.
Study II - Circadian variations of sodium levels in kidneys:
The aim of the study is to estimate circadian variations in the sodium gradient of the kidney with use of MRI in healthy volunteers, and to relate the MRI findings with the osmolarity proven in urine samples. The investigators hypothesize that the sodium level follows a circadian rhythm. If proven investigations of sodium level in kidney disease can develop. The investigators hypothesize that assessing the sodium level in humans will contribute to the diagnostic process of kidney disease in the future.
Materials and methods
MRI examinations:
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 - MR protocol:
The scan will be performed in four AOFs to acquire sodium level signal from 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 the following MRI sequences. An initial localization scan followed by evaluation of the main magnetic field inhomogeneities (B0 field map). Hereafter the radio frequencies (RF) of the scanner is calibrated (amplitude and frequency) for optimal sodium imaging and an evaluation of the sodium coil is achieved (B1+ field map). Finally, the sodium specific sequence is applied. The B0 and B1 maps are applied in pre-processing to account for magnetic field imperfections and improve sodium imaging robustness.
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.
Study II - MR protocol:
The main outcome is 23Na MRI images of the sodium level in kidneys. Furthermore, the investigators will perform blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI) to assess changes in renal oxygenation. The MRI examination also measures kidney size, T1, T2 relaxation assed by magnetic resonance fingerprinting (MRF), ADC (DWI), 23Na distribution (23Na MRI) and perfusion (pCASL).
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.
Study II - Examination day 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). 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.
- Conditions
- Image, Body, Sodium Disorder
- Being tested
- MRI examination
- Keywords
- MRI, Sodium imaging, B1 field correction, Kidney circadian sodium level variation, Multi-organ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI examinationDiagnostic 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: MRI examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
Study I: Multi-organ sodium imaging with B1 field correction
The aim of the study is to evaluate sodium levels in thigh, heart, kidney, and brain with the use of magnetic resonance imaging in healthy human subjects.
This initial study will determine the robustness of the sodium specific imaging method in determination of human sodium levels in different MR challenging conditions and organs. The study will provide the needed information to create an optimal scanning protocol for sodium imaging.
Measured: 6 months
Study II: Circadian sodium level variation in the kidney measured with MRI
The aim of the study is to estimate circadian variations in the sodium gradient of the kidney with use of MRI in healthy volunteers, and to relate the MRI findings with the osmolarity proven in urine samples. We hypothesize that the sodium level follows a circadian rhythm. If proven by our study, investigations of sodium level in kidney disease can develop. We hypothesise that assessing the sodium level in humans will contribute to the diagnostic process of kidney disease in the future.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start7 Jul 2021
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Image, BodyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215938
- Sponsor's protocol ID
- 1-10-72-210-21
- Status last verified
- Jan 2022
- First submitted
- 18 Jan 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study is performed on healthy subjects to evaluate sodium MR imaging feasibility. Even though results are of value to the field further studies would require inclusion of a patient group or an intervention.
Publications
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.
PubMed 37736981Rasmussen 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.
PubMed 37656067Christensen NV, Vaeggemose M, Bogh N, Hansen ESS, Olesen JL, Kim Y, Vigneron DB, Gordon JW, Jespersen SN, Laustsen C. A user independent denoising method for x-nuclei MRI and MRS. Magn Reson Med. 2023 Dec;90(6):2539-2556. doi: 10.1002/mrm.29817. Epub 2023 Aug 1.
PubMed 37526128
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intra Organ Sodium Levels by Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT05215938
- Acronym / sponsor ID
- 1-10-72-210-21
- Conditions
- Image, Body, Sodium Disorder
- Keywords
- MRI, Sodium imaging, B1 field correction, Kidney circadian sodium level variation, Multi-organ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background
Magnetic resonance imaging is considered the gold standard medical imaging modality for soft tissue characterization. The basic approach of MRI is acquiring resonance signal of proton (1H) spins which is abundant in soft tissue. In general, MRI scanner radio frequency antennas (RF coils) only tuned to transmit and receive at the frequency of hydrogen for proton imaging; however, it is possible to transmit and receive on other frequencies to create resonance images of different molecules.
Acquisition of other nuclei is performed with MR spectroscopy (MRS) and spectroscopic imaging (MRSI). For in vivo applications, common MR-active nuclei are protons (1H), phosphorus (31P), carbon (13C), sodium (23Na), and xenon (129Xe). Protons are the most common due to their high gyromagnetic ratio and natural abundance in the human body. Sodium is the second most abundant of the magnetic resonance sensitive nuclei.
Sodium MRI allows non-invasive examinations of intra-organ sodium concentrations and handling in vivo. These are coupled to electrophysiological and metabolic processes crucial to life. The methods have been thoroughly investigated in laboratory settings but has never made the transition to the clinic due to the inherently low signal to noise of sodium MRI [1]. Imaging is often challenged by a gyromagnetic ratio of about 1/4th of proton making the signal-to-noise ratio (SNR) of 23Na MRI about 6000 times lower than that of proton MRI [2]. Nevertheless, recent years has seen a renewed interest in sodium MRI due to major technical advances of MRI scanner systems and receive coils [1].
In vivo measurements of sodium levels are of special interest for determination of the energy dependent Na+/K+-ATPase (the sodium-potassium pump) - an important physiological transport process of healthy cells [3]-[5]. A transport process which is affected in many clinical conditions involving tissue injury, edema, or necrosis resulting in an increase of total sodium level [6].
Recent studies of sodium levels in healthy subjects have shown circadian variation of several physiological processes e.g. urine output, blood pressure and kidney function [7], [8]. A decrease in sodium excretion at night is showed in humans [7] and renal handling of sodium level is reported to follow circadian variations in mice [9]. It is therefore important to evaluate sodium imaging robustness, possible bias due to circadian variation, and a possible effect of disruption in the circadian rhythms leading to development or progression of certain diseases.
This study aims to evaluate the circadian rhythm in healthy human kidneys. If a circadian change of sodium levels is proven, further investigations of sodium level in diseases such as kidney disease can be developed. The results from this study will provide valuable information for assessment of sodium levels in humans and will contribute to the diagnostic process of multiple disease.
Aim
Increased recognition of the circadian variation is needed as it may result in a foundation for improved understanding of disease processes in several clinical conditions.
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:
Study I - Evaluation of sodium levels in thigh, heart, kidney, and brain:
The aim of the study is to evaluate sodium levels in thigh, heart, kidney, and brain with the use of magnetic resonance imaging in healthy human subjects.
This initial study will determine the robustness of the sodium specific imaging method in determination of human sodium levels in different MR challenging conditions and organs. The study will provide the needed information to create an optimal scanning protocol for sodium imaging.
Study II - Circadian variations of sodium levels in kidneys:
The aim of the study is to estimate circadian variations in the sodium gradient of the kidney with use of MRI in healthy volunteers, and to relate the MRI findings with the osmolarity proven in urine samples. The investigators hypothesize that the sodium level follows a circadian rhythm. If proven investigations of sodium level in kidney disease can develop. The investigators hypothesize that assessing the sodium level in humans will contribute to the diagnostic process of kidney disease in the future.
Materials and methods
MRI examinations:
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 - MR protocol:
The scan will be performed in four AOFs to acquire sodium level signal from 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 the following MRI sequences. An initial localization scan followed by evaluation of the main magnetic field inhomogeneities (B0 field map). Hereafter the radio frequencies (RF) of the scanner is calibrated (amplitude and frequency) for optimal sodium imaging and an evaluation of the sodium coil is achieved (B1+ field map). Finally, the sodium specific sequence is applied. The B0 and B1 maps are applied in pre-processing to account for magnetic field imperfections and improve sodium imaging robustness.
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.
Study II - MR protocol:
The main outcome is 23Na MRI images of the sodium level in kidneys. Furthermore, the investigators will perform blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI) to assess changes in renal oxygenation. The MRI examination also measures kidney size, T1, T2 relaxation assed by magnetic resonance fingerprinting (MRF), ADC (DWI), 23Na distribution (23Na MRI) and perfusion (pCASL).
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.
Study II - Examination day 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). 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study I: Multi-organ sodium imaging with B1 field correction | – | Diagnostic Test: MRI examinationThe 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. |
| Study II: Circadian sodium level variation in the kidney measured with MRI | – | Diagnostic Test: MRI examinationParticipation 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Healthy men and women in the ages of 20 to 60.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Exclusion criteria for the MRI are contraindication to MRI such as claustrophobia or the presence of a pacemaker or other implanted metallic device.
- Persons with circumference including arms > 160 cm. (MR scanner bore size)
- Pregnant women are not allowed to volunteer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI examinationThe 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. | Diagnostic test | Study I: Multi-organ sodium imaging with B1 field correction, Study II: Circadian sodium level variation in the kidney measured with MRI |
Primary outcome
Evaluation of intra organ sodium levels by magnetic resonance imaging
Time frame: 6 months
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.
2 secondary outcomes
Study I: Multi-organ sodium imaging with B1 field correction
Time frame: 6 months
Study II: Circadian sodium level variation in the kidney measured with MRI
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Derived from this study: PubMed 37736981Vaeggemose 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.
- Derived from this study: PubMed 37656067Rasmussen 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.
- Derived from this study: PubMed 37526128Christensen NV, Vaeggemose M, Bogh N, Hansen ESS, Olesen JL, Kim Y, Vigneron DB, Gordon JW, Jespersen SN, Laustsen C. A user independent denoising method for x-nuclei MRI and MRS. Magn Reson Med. 2023 Dec;90(6):2539-2556. doi: 10.1002/mrm.29817. Epub 2023 Aug 1.
- Individual participant dataSharing planned: No. The study is performed on healthy subjects to evaluate sodium MR imaging feasibility. Even though results are of value to the field further studies would require inclusion of a patient group or an intervention.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Image, Body and Sodium Disorder, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of intra organ sodium levels by magnetic resonance imaging (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05215938, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.