Evaluation of Advanced US Tools in Assessing Allograft Complications

Study Overview
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Brief Summary
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This study evaluates the role of advanced US technology in assessing renal transplants as screening tools such as 3D Ultrasound, Ultrasound SWE, and MFI besides current ultrasound conventional metheds.

Detailed Description
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This study will focus on monitoring renal after transplantation using all US advanced technology. Aim one will concentrate on the 3D US in assessing artery stenosis (TRAS) compared to the gold standard. Aim two focuses on will concentrate on Ultrasound elastography in assessing renal stiffness. Aim three will compare US colour modes such as PD, CD and MFI to assess renal perfusion in three groups. Duration: 18 Months; participants will have a patient information sheet; once they are happy to participate, consent will be obtained. Study data will be entered into a database encrypted and stored in the department. Only the study principal investigator (PI) will know the study database password.

Official Title
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The Evaluation of Advanced Ultrasonography Applications in the Assessment of Transplanted Kidney Complications

Conditions
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Renal Failure, Chronic Kidney Diseases, Failure,Kidney, Renal Artery Stenosis, Fibrosis, Complications

Intervention / Treatment
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* Device: 3D imaging


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA Patients ≥ 18 years. Tx patients. Gender. EXCLUSION CRITERIA Prisoners. Patients < 18 years. Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transplanted kidney<br>No intervention is required. Routine Doppler assessment + 3D scan + Shear wave elastography + MicrFlow Imaging will be immediately recorded afterwards | Device: 3D imaging<br>* The study will focus on the accuracy of ultrasound technology in assessing renal transplants. The entire assessment should not take more than 25 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak systolic velocity (cm/s). | Pean of the blood flow velocities in the artery/ vein peak systolic velocity ≥200 cm/s velocity difference between pre- and post-stenotic segments of 2:1 | 12 weeks | 
| Peak systolic velocity ratio (PSVR). | High velocity flow at the stenosis site divided by a reference velocity (normal before stenosis) | 12 weeks | 
| Resistive Index (RI). | An RI less than 0.7 to 0.8 is considered normal, more than that it is indicator of transplant dysfunction. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volumetric stenosis. | Plaque volume is calculated automatically with the aid of software with a package of 3D laptop. | 12 weeks | 
| 3D GSM. | Plaque volume is calculated automatically with the aid of software with a package of 3D laptop. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D Ultrasound, US elastography, US MFI, Ultrasound, MRI, CT