Assessment of Differential Renal Function by CT in Living Donors (DOVISCAN)

May 7, 2020 updated by: Central Hospital, Nancy, France

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54000
        • CHRU Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: All patients

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
degree of agreement
Time Frame: 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.
through study completion (2 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra- and inter-observer reproducibility of CT DRF measurement
Time Frame: through study completion (2 years)
through study completion (2 years)
Radiation dose exposure for each technique
Time Frame: 1 day
Additional radiation dose exposure (CTDIvol and DLP) will be recorded and follow-up
1 day
Agreement between post-processing methods for CT
Time Frame: through study completion (2 years)
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
Time Frame: through study completion (2 years)
through study completion (2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
University of Lorraine

Investigators

  • Principal Investigator: Damien Mandry, MD,PhD, CHRU Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 28, 2016

Primary Completion (ACTUAL)

June 25, 2018

Study Completion (ACTUAL)

June 25, 2018

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (ESTIMATE)

July 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 8, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2016-A00543-48
  • PSS 2016 / DOVISCAN - MANDRY / (OTHER: CentralHNF)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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