Clinical Trials Directory

Trials / Terminated

TerminatedNCT03780101

Pathology and Imaging in Kidney Allografts

Status
Terminated
Phase
Study type
Observational
Enrollment
29 (actual)
Sponsor
NHS Greater Glasgow and Clyde · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study will perform multi-parametric renal MRI in 70 patients with a renal transplant who are undergoing a clinically indicated biopsy of their transplant. The aim of this study is to compare findings on renal MRI with those seen on histology.

Detailed description

Background: Renal transplantation is the optimal treatment for patients with renal failure. However, transplant life-span is finite and commonly limited due to the development of chronic rejection and other causes of irreversible fibrosis. At present, renal transplant biopsy is required to diagnose the cause of transplant dysfunction. Renal biopsies are invasive procedures that carry risks of bleeding, damage to the transplant and discomfort to patients. Functional magnetic resonance imaging (MRI) of the kidneys is an emerging field of research that has potential to non-invasively define and quantify parenchymal renal disease including fibrosis and inflammation. There is a paucity of data correlating multi-parametric renal MRI sequences with histological findings on biopsy, especially in patients with renal transplants. Study participants: 70 adult renal transplant recipients who have been referred for a clinically indicated biopsy of their transplant kidney. Study design: Participants will undergo multi-parametric renal MRI at time of biopsy. In patients who receive treatment for acute rejection, a second renal MRI will be undertaken at completion of treatment. Blood tests for fibrosis biomarkers and routine clinical measures of transplant function will be obtained at time of MRI scanning. Objectives: 1. Assess the correlation between functional renal MRI sequences and histological markers of fibrosis and inflammation. 2. Assess the change in functional MRI sequences in response to treatment for acute rejection in renal transplant recipients.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTMulti-parametric renal MRIMulti-parametric functional magnetic resonance imaging of a transplant kidney including sequences for T1, T2, diffusion-weighted imaging, diffusion tensor imaging and arterial spin labelling.

Timeline

Start date
2019-02-15
Primary completion
2022-05-24
Completion
2022-05-24
First posted
2018-12-19
Last updated
2022-06-03

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03780101. Inclusion in this directory is not an endorsement.