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Living Renal Donor MRI Study

University Health Network, Toronto logo

University Health Network, Toronto

Status

Withdrawn

Conditions

Living Renal Donor

Treatments

Procedure: Magnetic Resonance Imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT01280851
UHN10-0202-A

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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