Living Renal Donor MRI Study

Not Applicable

Withdrawn

• Conditions: Living Renal Donor

• Registration Number: NCT01280851
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2011-01-19
• Study First Submitted QC: 2011-01-20
• Study First Posted: 2011-01-21
• Study Start: 2011-09
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-13
• Last Update Posted: 2012-01-18
• Primary Completion: 2013-09
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

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Exclusion Criteria

• Pregnancy;
• Age <18 years or >65 years;
• MRI contrast allergy, general contraindications to MRI such as pacemaker, etc.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Accuracy of MRI exam in kidney donors	2 years	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

Name	Time	Method
cost analysis	2 years	To perform a cost-analysis study to determine feasibility of replacing US, CT and Nuclear Scintigraphy by single MRI examination