Living Renal Donor MRI Study

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01280851
First received: January 19, 2011
Last updated: January 13, 2012
Last verified: January 2012
  Purpose

Accurate preoperative evaluation of a potential living renal donor's anatomy, vasculature and function is crucial to ensure optimal outcomes for both kidney donor and recipient in transplantation.

Currently abdominal ultrasound and spiral CT angiography are used to evaluate renal anatomy and vascular status, and renal scintigraphy to evaluate renal function. This imaging protocol exposes this relatively young and healthy population to a high radiation dose and potentially nephrotoxic contrast agents.

The investigators hypothesize that a single MR-based examination in the preoperative evaluation of potential kidney donor is a faster, safer, more cost effective and as accurate as the current multiple imaging work-up protocol.


Condition Intervention
Living Renal Donor
Procedure: Magnetic Resonance Imaging

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Comprehensive Morphological and Functional Assessment of Living Renal Donor With Magnetic Resonance Imaging With Comparison to Computed Tomographic Angiography and Renal Scintigraphy

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Accuracy of MRI exam in kidney donors [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To evaluate the accuracy of comprehensive Renal Magnetic Resonance Imaging (MRI) examination compared to CT angiography and Renal scintigraphy for the assessment of renal vascular anatomy and function in potential kidney donors.


Secondary Outcome Measures:
  • cost analysis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To perform a cost-analysis study to determine feasibility of replacing US, CT and Nuclear Scintigraphy by single MRI examination


Enrollment: 0
Study Start Date: September 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Magnetic Resonance Imaging
    1 hour of MRI exam will be performed in addition to the standard of care procedures, using low dose of gadolinium-based contrast (not investigational drug).
Detailed Description:

An accurate preoperative assessment of the renal donor is essential to minimize the risks for the donor & optimize the results for the recipient.

The current preoperative assessment includes Ultrasound, CT & Renal Scintigraphy. The latter two tests subjects the patient to the risk of a high radiation dose. Moreover, the use of iodinated contrast media during CT angiography may increase the risk of renal & systemic toxicity.

MRI can be a "one-stop shop" modality for preoperative assessment of living kidney donors. MRI also eliminates radiation exposure and the injection of potentially nephrotoxic iodinated contrast material.

The purpose of this study is to test the feasibility and evaluate the accuracy of a single MR-based examination, allowing for the comprehensive assessment of renal anatomy, function and vascular status in potential live kidney donors.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Potential renal donors with no known renal disease (initial medical screening performed and scheduled for further imaging evaluation as renal donor);
  • Age 18-65 years;
  • No medications (birth control pills and vitamins are acceptable).

Exclusion Criteria:

  • Pregnancy;
  • Age <18 years or >65 years;
  • MRI contrast allergy, general contraindications to MRI such as pacemaker, etc.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01280851

Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Kartik Jhaveri, MD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Dr. Kartik Jhaveri, University Health Network
ClinicalTrials.gov Identifier: NCT01280851     History of Changes
Other Study ID Numbers: UHN10-0202-A
Study First Received: January 19, 2011
Last Updated: January 13, 2012
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Living renal donor
Magnetic Resonance Imaging
Renal vascular anatomy
Renal function

ClinicalTrials.gov processed this record on September 22, 2014