An US Mathematical Model in Predicting Renal Transplant Rejection

March 17, 2021 updated by: Shanghai Zhongshan Hospital
The purpose of this study is to establish an ultrasound mathematical model using acoustic radiation force impulse (ARFI) and contrast-enhanced ultrasonography (CEUS) for diagnosing the status of renal allografts.

Study Overview

Status

Recruiting

Conditions

Detailed Description

  • There are various reasons for renal failure after kidney transplantation, such as delayed graft function (DGF) and acute rejection, acute renal tubular necrosis, chronic rejection and toxicity of immunosuppressive drugs. The diagnosis of renal allografts dysfunction can determine the direction of therapy. Currently, the gold standard of diagnosing renal allografts status is biopsies. However, biopsy has several drawbacks. It is invasive and can cause serious complications. These drawbacks urge investigators to find an accurate and non-invasive method to detect renal function. Elastography is a new way to detect tissue elasticity and can evaluate the tissue elasticity quantitatively. This method is proved to be of great value in diagnosing hepatic fibrosis (≥stage 2). Even though the investigation about this method is relatively less in allograft, the recent research shows that tissue elasticity does have relationship with pathological changes of transplanted kidney. Another new method, contrast-enhanced ultrasonography (CEUS), can indicate the blood perfusion of organ microcirculation. The accuracy rate of diagnosis of acute rejection(AR) can be 80% by using this method. It also has advantage in diagnosing acute tubular necrosis(ATN) and CAN. In addition, it produces no radioactive contamination as well as renal toxicity. This method has no serious side effect so it will not influence the normal function of patients' bodies and it can be performed for many times easily.
  • The research information about Elastography and CEUS is still at the primary stage. The value of one single parameter in diagnosing renal failure is restricted. So the establishment of an integrated mathematical model got by combining traditional methods (such as ultrasonography and color Doppler flow imaging) with these two new methods (Elastography and CEUS) is required to provide a systematical, multi-parameter diagnosis of allograft rejection.
  • What investigators have investigated before shows that different pathological changes of renal allograft can lead to regular changes in shear wave speed (SWS) and hemodynamics. By in-depth study of these changes, investigators aim to develop a mathematical model to diagnose the status of renal allograft.

  • To achieve this goal, the following things will be done:

    1. Investigators plan to enroll 100 renal transplant recipients .

    2. Before biopsy, these things will be done : a. Normal ultrasonography will be performed on transplanted kidney to measure their size, cortical thickness and vertebral body. b. Color Doppler flow imaging will be performed to see blood supply of transplanted kidney and resistive index (RI) of renal seg-mental will be measured. c. Contrast enhanced ultrasonography examination will be performed using Philips iU-22 ultrasonic apparatus with a C5-1 probe (Philips,Amsterdam, theNetherlands)with an intravenous bolus injection of 0.6-1.0mL SonoVue (Bracco, Milan, Italy). Area under curve (AUC), peak intensity (PI), time-to-peak (TTP), rise time (RT) and mean transit time (MTT) will be measured on central cortex of transplanted kidney. d. Elastography will be performed with a Siemens Acuson S2000 ultrasound machine using a 1- to 4-MHzcurved array multifrequency transducer (4 C1) (Siemens,Munich, Germany).

      Shear wave velocity (SWV) will be measured.

    3. Statistical analysis will be performed on the 10 quantitative parameters we got before (AUC, PI.etc ). The correlation between these parameters and condition of transplanted kidney (got by renal biopsy) will be evaluated. Then screening indexes will be optimized. On this basis, a mathematical model in diagnosing transplanted kidney is supposed to be built up.
    4. A ROC curve will be used to analyze the accuracy, sensitivity and specificity of this mathematical model.
    5. Then the US model will be verified in another 80 renal transplant recipients. Investigators will compare the diagnosis efficacy of transplanted kidney status got by the US model with the kidney biopsy result. Any parameter can be adjusted according to the verification results.

Study Type

Observational

Enrollment (Anticipated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults (over 18) who have undergone renal transplant for at Zhongshan Hospital.

Description

Inclusion Criteria:

  • Adults (over 18) who have undergone renal transplant at Zhongshan Hospital
  • Understanding the research situation
  • Signing informed consent voluntarily

Exclusion Criteria:

  • Urinary obstruction
  • Perirenal hematioma
  • Infection in operative sites

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Kidney transplant recipients
Patients who have received kidney transplantation in Zhongshan Hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The diagnosis of the status of kidney allografts from biopsy results
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

January 14, 2017

First Submitted That Met QC Criteria

February 4, 2017

First Posted (ESTIMATE)

February 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FDU-ZS-US-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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