NCT05851417

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 9, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

June 4, 2025

Status Verified

June 1, 2025

Enrollment Period

2.1 years

First QC Date

May 1, 2023

Last Update Submit

June 3, 2025

Conditions

Kidney Diseases

Keywords

Kidney diseasesFast Field-Cycling imaging

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Live donors

EXPERIMENTAL

Live kidney donors (healthy volunteers).

Device: Fast Field-Cycling (FFC) imaging

Native kidney damage

EXPERIMENTAL

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

Device: Fast Field-Cycling (FFC) imaging

Kidney transplants

EXPERIMENTAL

Patients with kidney transplant.

Device: Fast Field-Cycling (FFC) imaging

Interventions

Fast Field-Cycling (FFC) imagingDEVICE

FFC scan

Kidney transplantsLive donorsNative kidney damage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Grampian

Aberdeen, AB25 2ZD, United Kingdom

Location

MeSH Terms

Conditions

Kidney Diseases

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Simon Sawhney, Dr

    NHS Grampian

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2023

First Posted

May 9, 2023

Study Start

March 8, 2023

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

June 4, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)