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Clinical Trial Summary

Iodine-123 labelled ortho-Iodohippuric Acid ([I-123]-OIH) was used in the early 1970's as a kidney imaging agent or tracer that "lights-up" inside your body when scanned, but over the years its use has declined. The most commonly used tracer is Technetium-99m labelled Mercaptoacetyltriglycine ([Tc-99m]-Mertiatide or [Tc-99m]-MAG3). However, long-term shortages may threaten the supply of the radioactive substance Tc-99m in Canada and the world. As a result of such shortages, there is a need to identify other types of tracers that can be used for imaging. [I-123]-OIH may be an alternative.

The purpose of this study is to examine the diagnostic performance characteristics of [I-123]-OIH in comparison to [Tc-99m]-MAG3.


Clinical Trial Description

This study is being conducted to compare two imaging agents (tracers): [I-123]-OIH and [Tc-99m]-MAG3 using gamma camera imaging in participants with different levels of kidney function. Gamma camera imaging is a non-invasive nuclear scan that is used to look at organs and tissues inside the body. An imaging agent or tracer is a radioactive chemical intravenously injected into your body which lights up cells, tissues and organs. The study will evaluate the safety of a single injection of [I-123]-OIH and compare the imaging results and the calculated renal function values (using blood tests) to those of [Tc-99m]-MAG3 . 90 participants are required to complete this study. ;


Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01496391
Study type Observational
Source Centre for Probe Development and Commercialization
Contact
Status Completed
Phase N/A
Start date September 2012
Completion date April 2014