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

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ClinicalTrials.gov Identifier: NCT02820376
Recruitment Status : Active, not recruiting
First Posted : July 1, 2016
Last Update Posted : September 18, 2018
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
University of Lorraine
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Living Donor of Kidney Other: Differential renal function assessment by 4D CT Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Differential Renal Function by CT in Living Donors - The DOVISCAN Study
Actual Study Start Date : June 28, 2016
Actual Primary Completion Date : June 25, 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02820376


Locations
France
CHRU Nancy
Nancy, France, 54000
Sponsors and Collaborators
Central Hospital, Nancy, France
Institut National de la Santé Et de la Recherche Médicale, France
University of Lorraine
Investigators
Principal Investigator: Damien Mandry, MD,PhD CHRU Nancy

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02820376     History of Changes
Other Study ID Numbers: 2016-A00543-48
PSS 2016 / DOVISCAN - MANDRY / ( Other Identifier: CentralHNF )
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Central Hospital, Nancy, France:
4D computed tomography
Kidney function tests
Living Donors