Assessment of Differential Renal Function by CT in Living Donors

NCT ID: NCT02820376

Last Updated: 2020-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-28

Study Completion Date

2018-06-25

Brief Summary

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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

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Conditions

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Living Donor of Kidney

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Differential renal function assessment by 4D CT

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University of Lorraine

OTHER

Sponsor Role collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Damien Mandry, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

CHRU Nancy

Locations

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CHRU Nancy

Nancy, , France

Site Status

Countries

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France

Other Identifiers

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PSS 2016 / DOVISCAN - MANDRY /

Identifier Type: OTHER

Identifier Source: secondary_id

2016-A00543-48

Identifier Type: -

Identifier Source: org_study_id

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