Assessment of Differential Renal Function by CT in Living Donors

Not Applicable

Completed

• Conditions: Living Donor of Kidney
• Interventions: Other: Differential renal function assessment by 4D CT

• Registration Number: NCT02820376
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-20
• Study Start: 2016-06-28
• Study First Submitted QC: 2016-06-28
• Study First Posted: 2016-07-01
• Primary Completion: 2018-06-25
• Study Completion: 2018-06-25
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-07
• Last Update Posted: 2020-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	Differential renal function assessment by 4D CT	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

Primary Outcome Measures

Name	Time	Method
degree of agreement	through study completion (2 years)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHRU Nancy; 🇫🇷 Nancy, France