Image, Body Clinical Trial
Official title:
Evaluation of Intra Organ Sodium Levels by Magnetic Resonance Imaging
Verified date | January 2022 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | December 10, 2021 |
Est. primary completion date | December 10, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility | Inclusion criteria: 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. Exclusion criteria: 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | MR Research Centre | Aarhus N |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | GE Healthcare |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. |
6 months | |
Secondary | 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. | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03291964 -
Rapid MRI for Acute Pediatric Head Trauma
|
||
Completed |
NCT03129516 -
Turkish Version of the Movement Imagery Questionnaire-3
|
N/A | |
Recruiting |
NCT04214522 -
Reliability and Validity of the Kinesthetic and Visual Imagery Questionnaire in Acute Stroke Patients
|
||
Terminated |
NCT03219567 -
Whole Eye Optical Coherence Tomography (OCT) to Improve Refractive Surgery and Eye Care
|
||
Completed |
NCT04193072 -
Imagery Ability in Obstetric Brachial Plexus Palsy
|
||
Completed |
NCT05196776 -
Diagnostic Accuracy of Handheld vs Traditional Ultrasound
|
N/A | |
Recruiting |
NCT05353309 -
Iliac Angioplasties: Impact of the Fusion of Images on the Irradiation Rate
|
N/A | |
Recruiting |
NCT05355558 -
A Novel Functional Imaging Technique With FLT-PET/MRI For Staging, Response Assessment and Radiation Treatment Planning in Cervix Cancer
|
N/A | |
Recruiting |
NCT04944680 -
Dual Channel Rehabilitation Technology Promotes Rapid Recovery of Upper Limbs After Stroke
|
N/A | |
Recruiting |
NCT04490317 -
CARbon monoxidE intoxiCatiOn in Korea: Prospective Cohort (CARE CO Cohort)
|
||
Completed |
NCT03870932 -
Effects of a Motor Imagery Exercise Protocol in Patients With Fibromyalgia
|
N/A | |
Not yet recruiting |
NCT05999565 -
Investigation of the Effect of Motor Imagery Training in Individuals With Cervical Discogenic Pain
|
N/A | |
Completed |
NCT04009356 -
Impact of Bariatric Surgery in Patients With Morbid Obesity
|
||
Completed |
NCT03120858 -
Turkish Version of the Kinesthetic and Visual Imagery Questionnaire
|
N/A | |
Recruiting |
NCT05622565 -
Explainable Ocular Fundus Diseases Report Generation System
|
||
Completed |
NCT03648151 -
Influence of PET/CT Radiomic Features on the Outcome of Lung Cancer Patients
|
||
Recruiting |
NCT04528875 -
Augmenting Ultrasound Imaging in Order to Replace Fluoroscopy in Image Guided Pain Procedures
|
||
Recruiting |
NCT05215132 -
Investigational MRI Clinical Software and Hardware
|
Phase 4 | |
Not yet recruiting |
NCT04461990 -
Clinical Study of Imaging Genomics Based on Machine Learning for BCIG
|
||
Not yet recruiting |
NCT05445388 -
Feasibility of Middle Ear OCT Imaging
|
N/A |