Pathology and Imaging in Kidney Allografts

NCT ID: NCT03780101

Last Updated: 2022-06-03

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 29 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2022-05-24

Brief 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

Renal Transplant Rejection; Chronic Kidney Diseases; Fibrosis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Multi-parametric renal MRI

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age > 18 years
• Recipient of a kidney transplant
• Referred for clinically indicated biopsy of transplant kidney
• Ability to comply with study procedures.
• Ability to give informed consent.

Exclusion Criteria

• Any contraindication to MRI
• Known pregnancy or intent to conceive during the study period
• Clinical suspicion of delayed graft function as the cause of transplant dysfunction
• Any other reason considered by a study physician to make the subject inappropriate for inclusion.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alastair J Rankin, MBChB

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Locations

NHS Greater Glasgow & Clyde

Glasgow, , United Kingdom

Countries

United Kingdom

Other Identifiers

248675

Identifier Type: OTHER

Identifier Source: secondary_id

GN18RE474

Identifier Type: -

Identifier Source: org_study_id