NCT01496391

A Single Centre Open Label Comparison of [I-123]-Ortho-Iodohippuric Acid (OIH) With [Tc-99m]-Mercaptoacetyltriglycine (MAG3) for Assessment of Renal Tubular Function

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: Centre for Probe Development and Commercialization · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Renal Function Impairment

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-05-01
• Completion: 2014-04-01
• First posted: 2011-12-21
• Last updated: 2014-04-09

Locations

1 site across 1 country: Canada