Pathology and Imaging in Kidney Allografts
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Comparison of MRI biomarkers for fibrosis with histology
Study Overview
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:
- Assess the correlation between functional renal MRI sequences and histological markers of fibrosis and inflammation.
- Assess the change in functional MRI sequences in response to treatment for acute rejection in renal transplant recipients.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Comparison of MRI biomarkers for fibrosis with histology
Time Frame: Baseline
Correlation between diffusion weighted imaging on renal MRI and reported percentage of cortical area on biopsy showing interstitial fibrosis.
Secondary Outcomes
- Renal MRI following treatment for acute rejection(2 weeks)