Kidney DiseasesNCT05851417
Fast Field Cycling Imaging of Kidney Disease
A study testing Fast Field-Cycling (FFC) imaging in people with Kidney Diseases, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- Fast Field-Cycling (FFC) imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Mar 2023to 30 Apr 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants:
- Participants must be aged 18 and above
- Participants who meet the safety criteria for undergoing an MRI scan.
- Participants who can pass through a 50 cm-diameter circular hoop to ensure they will be able to fit inside the scanner
- Participants must be able to give fully informed consent.
- Participants must be mobile enough to be positioned onto the FFC-MRI scanner couch.
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- Native kidney damage patients:
- Patients referred for a kidney biopsy and laboratory evidence (blood tests and urine abnormalities) of kidney impairment.
- Patients who are newly referred.
- Transplant patients:
- Patients with functioning kidney transplant undergoing a kidney biopsy as a part of routine clinical care.
- Patients who are newly referred.
- Live donors
- Live kidney donors, patients investigated for potential kidney donation and deemed suitable for donation.
Who cannot join
- Native kidney Damage Patients:
- Patients with single native kidney.
- Patients on dialysis.
- Transplant patients:
- Patients with non-functioning kidney transplant.
- Live donors
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- Live donors who deemed unsuitable for kidney donation by the living kidney donation clinic.
- All participants:
- MRI-incompatible conditions, as detected in the MRI safety screening sheet.
- Participants under 18 years old.
- Participants who are unable to give fully informed consent.
- Women who are pregnant.
- Restrictions to mobility that would prevent the correct positioning in the scanner.
- Participants who suffer from claustrophobia.
- Body mass index larger than 34, due to the limited bore size of the scanner.
- Participants who are unable to communicate in English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating a Novel Molecular Imaging Technique, Fast Field-Cycling, for Kidney Health and Disease
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.
Read the 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.
- Conditions
- Kidney Diseases
- Being tested
- Fast Field-Cycling (FFC) imaging
- Keywords
- Kidney diseases, Fast Field-Cycling imaging
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast Field-Cycling (FFC) imagingDevice
FFC scan
| Study group | Role | What they receive |
|---|---|---|
| Live donors | Experimental | Live kidney donors (healthy volunteers). Receives: Device: Fast Field-Cycling (FFC) imaging |
| Native kidney damage | Experimental | Patients with native kidney damage (suspected active glomerular or interstitial lesion). Receives: Device: Fast Field-Cycling (FFC) imaging |
| Kidney transplants | Experimental | Patients with kidney transplant. Receives: Device: Fast Field-Cycling (FFC) imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start8 Mar 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian
- Responsible party
- Sponsor
- Investigators
- Simon Sawhney, Dr, Study chair, NHS Grampian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851417
- Sponsor's protocol ID
- 2-095-21
- Status last verified
- Jun 2025
- First submitted
- 1 May 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating a Novel Molecular Imaging Technique, Fast Field-Cycling, for Kidney Health and Disease
- ClinicalTrials.gov ID
- NCT05851417
- Acronym / sponsor ID
- 2-095-21
- Conditions
- Kidney Diseases
- Keywords
- Kidney diseases, Fast Field-Cycling imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- NHS Grampian
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 9 May 2023 (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 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Live donors | Experimental | Device: Fast Field-Cycling (FFC) imagingLive kidney donors (healthy volunteers). |
| Native kidney damage | Experimental | Device: Fast Field-Cycling (FFC) imagingPatients with native kidney damage (suspected active glomerular or interstitial lesion). |
| Kidney transplants | Experimental | Device: Fast Field-Cycling (FFC) imagingPatients with kidney transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Participants must be aged 18 and above
- Participants who meet the safety criteria for undergoing an MRI scan.
- Participants who can pass through a 50 cm-diameter circular hoop to ensure they will be able to fit inside the scanner
- Participants must be able to give fully informed consent.
- Participants must be mobile enough to be positioned onto the FFC-MRI scanner couch.
Key exclusion criteria (16 listed)
- Patients with single native kidney.
- Patients on dialysis.
- Patients with non-functioning kidney transplant.
- Live donors
- Live donors who deemed unsuitable for kidney donation by the living kidney donation clinic.
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 |
|---|---|---|
| Fast Field-Cycling (FFC) imagingFFC scan | Device | Kidney transplants, Live donors, Native kidney damage |
Primary outcome
Kidney microstructure assessed by Fast Field Cycling (FFC) imaging scan
Time frame: At baseline
Evaluating the potential of FFC T1 dispersion profiles in the clinical assessment of kidney microstructure
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 4 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Simon Sawhney, Dr study chair
NHS Grampian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast Field-Cycling (FFC) imaging in people with Kidney Diseases, run by University of Aberdeen at 1 site in United Kingdom.
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 14 inclusion and 16 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 4 Jun 2025. 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 United Kingdom. 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?
Kidney microstructure assessed by Fast Field Cycling (FFC) imaging scan (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2025.