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This study has been withdrawn prior to enrollment.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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 19, 2011

Last Updated Date

January 13, 2012

Start Date ^ICMJE

September 2011

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01280851 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Living Renal Donor MRI Study

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Living Renal Donor

Intervention ^ICMJE

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).

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Estimated Completion Date

September 2013

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01280851

Other Study ID Numbers ^ICMJE

UHN10-0202-A

Has Data Monitoring Committee

Responsible Party

Dr. Kartik Jhaveri, University Health Network

Study Sponsor ^ICMJE

University Health Network, Toronto

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kartik Jhaveri, MD

University Health Network, Toronto

Information Provided By

University Health Network, Toronto

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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