Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05851417
Status:
RECRUITING
Last Update Posted:
2023-05-09
First Post:
2023-05-01
Brief Title:
Fast Field Cycling Imaging of Kidney Disease
Sponsor:
University of Aberdeen
Organization:
University of Aberdeen
Study Overview
Official Title:
Investigating a Novel Molecular Imaging Technique Fast Field-Cycling for Kidney Health and Disease
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
If FFC imaging can differentiate healthy kidney from kidney disease
If there is an association between FFC imaging and standard clinical tests Participants will provide one blood and on urine sample and will have one FFC imaging scan
If FFC imaging can differentiate healthy kidney from kidney disease
If there is an association between FFC imaging and standard clinical tests Participants will provide one blood and on urine sample and will have one FFC imaging scan
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None