Assessment of Differential Renal Function by CT in Living Donors

Living Donor of Kidney Clinical Trial

— DOVISCAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02820376
• Other study ID #: 2016-A00543-48
• Secondary ID: PSS 2016 / DOVIS
• Status: Completed
• Phase: N/A
• Start date: June 28, 2016
• Est. completion date: June 25, 2018

Study information

• Verified date: May 2020
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 25, 2018
• Est. primary completion date: June 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Living Donor of Kidney

Intervention

Other:
• Differential renal function assessment by 4D CT
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

Locations

Country	Name	City	State
France	CHRU Nancy	Nancy

Sponsors (3)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Institut National de la Santé Et de la Recherche Médicale, France, University of Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intra- and inter-observer reproducibility of CT DRF measurement		through study completion (2 years)
Secondary	Radiation dose exposure for each technique	Additional radiation dose exposure (CTDIvol and DLP) will be recorded and follow-up	1 day
Secondary	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)
Secondary	Automatic post-processing for Patlak-Ruthland method		through study completion (2 years)