Living Renal Donor MRI Study

Living Renal Donor Clinical Trial

Official title:

Comprehensive Morphological and Functional Assessment of Living Renal Donor With Magnetic Resonance Imaging With Comparison to Computed Tomographic Angiography and Renal Scintigraphy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01280851
• Other study ID #: UHN10-0202-A
• Status: Withdrawn
• Phase: N/A
• First received: January 19, 2011
• Last updated: January 13, 2012
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: January 2012
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Living Renal Donor

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of MRI exam in kidney donors	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.	2 years	No
Secondary	cost analysis	To perform a cost-analysis study to determine feasibility of replacing US, CT and Nuclear Scintigraphy by single MRI examination	2 years	No