NCT01280851

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 18, 2012

Status Verified

January 1, 2012

Enrollment Period

2 years

First QC Date

January 19, 2011

Last Update Submit

January 13, 2012

Conditions

Living Renal Donor

Keywords

Living renal donorMagnetic Resonance ImagingRenal vascular anatomyRenal function

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • cost analysis

    2 years

Interventions

Magnetic Resonance ImagingPROCEDURE

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).

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Kartik Jhaveri, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 19, 2011

First Posted

January 21, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

January 18, 2012

Record last verified: 2012-01