Ignite Creation Date:
2024-05-06 @ 12:06 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01496391
Status:
COMPLETED
Last Update Posted:
2014-04-09
First Post:
2011-12-18
Brief Title:
A Single Centre Open Label Comparison of I-123-Ortho-Iodohippuric Acid OIH With Tc-99m-Mercaptoacetyltriglycine MAG3 for Assessment of Renal Tubular Function
Sponsor:
Centre for Probe Development and Commercialization
Organization:
Centre for Probe Development and Commercialization
Study Overview
Official Title:
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
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Iodine-123 labelled ortho-Iodohippuric Acid I-123-OIH was used in the early 1970s 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None