Kidney Sodium Functional Imaging
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: Sodium-23 MRI.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease, Nephrolithiasis, ADPKD. Basic parameters: from 18 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
- Canada
- 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 →
Official title
Kidney Sodium Functional Imaging: Evaluation of Kidney Medullary Sodium Content Using 23Na MRI in Kidney Disease
Overview
The corticomedullary gradient is largely responsible for developing the gradients that are needed to concentrate urine (more solutes and less water). The ability of the kidneys to produce concentrated urine is a major determinant of the ability to survive the warm weather. When temperatures are high, we lose water through sweat, and so the kidneys retain water to maintain fluidity in the blood. The maintenance of a sodium (salt) gradient is required for urine concentration because increased medullary sodium concentration increases the reabsorption of water into the kidney, to be redistributed in the blood. The purpose of this study is to know if the corticomedullary gradient is altered in patients across a wide spectrum of kidney disease using sodium Magnetic Resonance Imaging (MRI), a machine that takes pictures and measures the salt content in the kidneys. 23Na kidney MRI, will provide functional MR of the kidney as a non-invasive tool to describe medullary function to improve management of chronic and kidney disease.
Detailed description
This study is a pilot exploratory study (preliminary project to assess the use of a kidney sodium coil across a wide spectrum of kidney disease). Approximately 200 patients from the London Health Sciences Regional Renal Program will be recruited. This study involves two visits at Robarts Research Institute or St. Joseph's Hospital, London, Ontario depending on scanner availability, lasting approximately 2 hours.
At the first study visit participants will undergo a sodium MRI scan of your kidneys. Prior to the scan, participants will have their sitting blood pressure and heart rate measured three times consecutively using a standard automatic blood pressure monitor. In addition to this, participants will be asked to provide a spot urine sample and have blood work done. If participants have been treated for nephrolithiasis, they will be responsible for completing a 24-hour urine volume test sometime the week before the MRI scan.
Interventions
- Diagnostic test Sodium-23 MRI
Participants will lay in the MRI bed for approximately 60 minutes during scanning while the MRI technologist takes detailed pictures of their kidneys.
Primary outcome measures
- Exploratory cortico-medullary gradient measurement [Time frame: Throughout study visit, on average 2 hours]
Secondary outcome measures (8)
- Urinary osmolarity [Time frame: Throughout study visit, on average 2 hours]
- Renal Function [Time frame: Throughout study visit, on average 2 hours]
- Native and transplanted kidney [Time frame: Throughout study visit, on average 2 hours]
- Kidney biopsy [Time frame: Throughout study visit, on average 2 hours]
- Residual renal function [Time frame: Throughout study visit, on average 2 hours]
- Nephrolithiasis [Time frame: Throughout study visit, on average 2 hours]
- ADPKD [Time frame: Throughout study visit, on average 2 hours]
- Clinical practice [Time frame: Throughout study visit, on average 2 hours]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- For healthy controls: lack of kidney disease, heart failure, liver cirrhosis and peripheral edema
- For CKD stage 1-5: Estimated GFR < 90 mL/min/1.73m²
- For patients on maintenance hemodialysis or peritoneal dialysis: more than 3 months duration of therapy
Exclusion criteria
- Pregnant, breastfeeding or intending pregnancy
- Contraindication to MRI
- Inability to tolerate MRI due to patient size and/or known history of claustrophobia.
- Mechanically implanted, electrically, or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, tattoos, shunt, surgical staples (including clips or metallic sutures and/or ear implants.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- Victoria Hospital, London Health Sciences Centre — London
Publications
- Lemoine S, Akbari A, Brahm G, Dorie J, Tamasi T, Penny J, McIntyre CW. Redefining the concept of residual renal function with kidney sodium MRI: a pilot study. Nephrol Dial Transplant. 2024 Oct 30;39(11):1809-1816. doi: 10.1093/ndt/gfae070. PMID 38688870
Identifiers
NCT: NCT05014178 · 118638