search
Back to results

Fast Field Cycling Imaging of Kidney Disease

Primary Purpose

Kidney Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Fast Field-Cycling (FFC) imaging
Sponsored by
University of Aberdeen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Kidney Diseases focused on measuring Kidney diseases, Fast Field-Cycling imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. 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. Exclusion Criteria: Native kidney Damage Patients: Patients with single native kidney. Patients on dialysis. 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: 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.

Sites / Locations

  • NHS GrampianRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Live donors

Native kidney damage

Kidney transplants

Arm Description

Live kidney donors (healthy volunteers).

Patients with native kidney damage (suspected active glomerular or interstitial lesion).

Patients with kidney transplant.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 1, 2023
Last Updated
May 1, 2023
Sponsor
University of Aberdeen
Collaborators
NHS Grampian
search

1. Study Identification

Unique Protocol Identification Number
NCT05851417
Brief Title
Fast Field Cycling Imaging of Kidney Disease
Official Title
Investigating a Novel Molecular Imaging Technique, Fast Field-Cycling, for Kidney Health and Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aberdeen
Collaborators
NHS Grampian

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases
Keywords
Kidney diseases, Fast Field-Cycling imaging

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Live donors
Arm Type
Experimental
Arm Description
Live kidney donors (healthy volunteers).
Arm Title
Native kidney damage
Arm Type
Experimental
Arm Description
Patients with native kidney damage (suspected active glomerular or interstitial lesion).
Arm Title
Kidney transplants
Arm Type
Experimental
Arm Description
Patients with kidney transplant.
Intervention Type
Device
Intervention Name(s)
Fast Field-Cycling (FFC) imaging
Intervention Description
FFC scan
Primary Outcome Measure Information:
Title
Kidney microstructure assessed by Fast Field Cycling (FFC) imaging scan
Description
Evaluating the potential of FFC T1 dispersion profiles in the clinical assessment of kidney microstructure
Time Frame
At baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: Native kidney Damage Patients: Patients with single native kidney. Patients on dialysis. 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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Celia G Alvarez Campano, Dr
Phone
+441224437828
Email
celia.alvarezcampano@abdn.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Sawhney, Dr
Organizational Affiliation
NHS Grampian
Official's Role
Study Chair
Facility Information:
Facility Name
NHS Grampian
City
Aberdeen
ZIP/Postal Code
AB25 2ZD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Kidder, Dr
Phone
01224553815
Email
dana.kidder@nhs.scot

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Fast Field Cycling Imaging of Kidney Disease

We'll reach out to this number within 24 hrs