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| Name | Class |
|---|---|
| NHS Grampian | OTHER_GOV |
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The goal of this pilot study is to explore the utility of Fast Field-Cycling (FFC) imaging in monitoring kidney disease. The main questions it aims to answer are:
The kidneys are vital organs responsible for clearance of toxins in the human body. The kidneys age over time and this ageing process is complex, involving changes both to their structure and function, and can be accelerated by disease processes. Without an invasive biopsy procedure, it is often difficult to distinguish between age-related damage from active disease, that could be modified with treatment. Even with a biopsy, certain diseases are often patchy and can be overlooked if missed by the biopsy sample procedure. Alternative imaging approaches have limited ability to differentiate between modifiable and non-modifiable disease processes.
The investigators, based at the University of Aberdeen, have developed a unique magnetic imaging technology, Fast Field-Cycling (FFC) imaging. FFC derives from conventional MRI scanners but has the ability to change its magnetic field strength during a scan. This is equivalent to having many MRI scanners in one device and allows completely new analyses of the behaviour of tissue remodelling to pathological processes, from millimetres to nanometres. This information is invisible to standard MRI scanners and several pilot studies have shown great potential for FFC in cancer and stroke.
This pilot study aims to investigate if FFC can detect changes in kidney microstructure. If FFC imaging shows that it is effective in monitoring kidney disease, then this would contribute to evidence from previous studies promoting the need to develop a new scanner that could be used clinically in the future.
The study will include 20 patients with kidney damage (native or transplant kidneys) and 10 live donors (healthy volunteers). Each participant (patients and live donors) will have urine and blood tests, along with an FFC-MRI scan.
Data analyses will be performed using the appropriate statistical methods depending on the distribution of the variables extracted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Live donors | Experimental | Live kidney donors (healthy volunteers). |
|
| Native kidney damage | Experimental | Patients with native kidney damage (suspected active glomerular or interstitial lesion). |
|
| Kidney transplants | Experimental | Patients with kidney transplant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fast Field-Cycling (FFC) imaging | Device | FFC scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Kidney microstructure assessed by Fast Field Cycling (FFC) imaging scan | Evaluating the potential of FFC T1 dispersion profiles in the clinical assessment of kidney microstructure | At baseline |
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Inclusion Criteria:
All participants:
Native kidney damage patients:
Transplant patients:
Live donors
• Live kidney donors, patients investigated for potential kidney donation and deemed suitable for donation.
Exclusion Criteria:
Native kidney Damage Patients:
Transplant patients:
• Patients with non-functioning kidney transplant.
Live donors
• Live donors who deemed unsuitable for kidney donation by the living kidney donation clinic.
All participants:
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| Name | Affiliation | Role |
|---|---|---|
| Simon Sawhney, Dr | NHS Grampian | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHS Grampian | Aberdeen | AB25 2ZD | United Kingdom |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D052801 | Male Urogenital Diseases |