Assessment of Differential Renal Function by CT in Living Donors

Study Overview
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Brief Summary
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The purpose of this study is to assess the degree of agreement of the measurement of differential renal function in living donors by CT (computed tomography) and SPECT (single photon emission computed tomography).

Official Title
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Assessment of Differential Renal Function by CT in Living Donors - The DOVISCAN Study

Conditions
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Living Donor of Kidney

Intervention / Treatment
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* Other: Differential renal function assessment by 4D CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Kidney living donor candidate (approval given) undergoing a morphological and functional renal assessment Mandatory enrollment in a health security plan (French Social Security) Subject having signed an informed consent Exclusion Criteria: Contra-indications to computed tomography with iodinated contrast medium injection, or to scintigraphy Subjects with an abnormal urinary tract (unique kidney, ectopic kidney, horseshoe kidney) Subjets under a legal protection measure

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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Accepts Healthy Volunteers

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: All patients<br>Differential renal function assessment by 4D CT: All patients will undergo both CT and SPECT assessment of differential renal function; each patient will be his own comparator | Other: Differential renal function assessment by 4D CT<br>* Low dose 4D (perfusion) renal acquisition after injection of iodinated contrast medium (ICM) (13 passes every 3 seconds, 3 passes every 10 seconds); estimated additional DLP 400 mGy.cm No additional contrast medium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of agreement | Differential renal function (DRF) measured by each technique (CT and SPECT) Regions of interest will be drawn on each kidney and the aorta to obtain time-intensity curves and derive the Patlak plot; the Patlak model will then be used to determine the slope of each kidney and thus to calculate the differential renal function (percentage of each kidney in the total renal function). Degree of agreement will be assessed by calculating the intra-class correlation coefficient and its 95% confidence interval, and the Bland-Altman plot. | through study completion (2 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra- and inter-observer reproducibility of CT DRF measurement |  | through study completion (2 years) | 
| Radiation dose exposure for each technique | Additional radiation dose exposure (CTDIvol and DLP) will be recorded and follow-up | 1 day | 
| Agreement between post-processing methods for CT | Comparison between Patlak-Ruthland method, its modified version and the area under the curve method | through study completion (2 years) | 
| Automatic post-processing for Patlak-Ruthland method |  | through study completion (2 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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4D computed tomography, Kidney function tests, Living Donors