Elastographic Imaging of Renal Transplants

Study Overview
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Brief Summary
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The study was developed to acquire images of normal, then abnormal, then unknown diagnosis for transplanted kidneys in order to determine whether the elastography imaging modality, a type of ultrasound imaging, can provide data useful for diagnosis of renal transplant abnormalities. The specific aims of this study are: To define normal elastography imaging by correlation with clinical findings. To define specific abnormal elastography images by correlation with clinical findings. To determine whether elastography could be useful in early diagnosis of abnormalities of renal transplants, especially in early rejection.

Detailed Description
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The study is collecting standard ultrasound and elastographic images of transplanted kidneys in order to perfect the imaging technique to get the best pictures, and to evaluate these images for characteristics that may be of diagnostic value.

Official Title
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Pilot Study to Define Parameters of Elastography Compared to Color Flow Doppler Ultrasound in Renal Transplants

Conditions
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Renal Transplant

Intervention / Treatment
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* Other: Elastographic imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (over 18) male or female renal transplant patient normally functioning or being evaluated for a possible problem Exclusion Criteria: unwilling or unable to give informed consent

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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>normally functioning transplanted kidneys | Other: Elastographic imaging<br>* ultrasound imaging using a specialized computer that processes the data for tissue hardness<br>|
| Other: 2<br>transplanted kidney undergoing known rejection or other known abnormality | Other: Elastographic imaging<br>* ultrasound imaging using a specialized computer that processes the data for tissue hardness<br>|
| Other: 3<br>transplanted kidney with unknown diagnosis | Other: Elastographic imaging<br>* ultrasound imaging using a specialized computer that processes the data for tissue hardness<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of features of a set of elastography images that can be characterized as those of a normally functioning transplanted kidney, or those of specific abnormalities |  | after up to 50 normal images are collected | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the value of renal transplant imaging by elastography compared to standard ultrasound |  | by the time up to 100 images are obtained | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal transplant, ultrasound, elastography