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Completed

NCT Number: NCT02820376

Assessment of Differential Renal Function by CT in Living Donors

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).

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Key information

Conditions

Living Donor of Kidney

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Nancy

Nancy, 54000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Differential renal function assessment by 4D CT

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Intra- and inter-observer reproducibility of CT DRF measurement

    Time frame: through study completion (2 years)

  2. Radiation dose exposure for each technique

    Time frame: 1 day

    Additional radiation dose exposure (CTDIvol and DLP) will be recorded and follow-up

  3. 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

  4. Automatic post-processing for Patlak-Ruthland method

    Time frame: through study completion (2 years)

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

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

Registry information

Official study title

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

Acronym: DOVISCAN

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 1, 2016
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.