A Single Centre Open Label Comparison of [I-123]-Ortho-Iodohippuric Acid (OIH) With [Tc-99m]-Mercaptoacetyltriglycine (MAG3) for Assessment of Renal Tubular Function
|ClinicalTrials.gov Identifier: NCT01496391|
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : April 9, 2014
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.
|Condition or disease|
|Renal Function Impairment|
|Study Type :||Observational|
|Actual Enrollment :||6 participants|
|Observational Model:||Case Control|
|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|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||April 2014|
eGFR ≥60 ml/min/1.73m^2, healthy prospective kidney donor
Moderate Renal Function Impairment
eGFR 30-59 ml/minute/1.73m^2
Severe Renal Function Impairment
eGFR <30 mL/minute/1.73m^2
- [I-123]-OIH Safety [ Time Frame: Visit 3 and Follow-up Phone Call ]Evaluate the safety of a single injection of [I-123]-OIH administered to a population of healthy prospective kidney donors and patients with stable chronic renal impairment.
- Compare kidney function using [I-123]-OIH and [Tc-99m]-MAG3 imaging [ Time Frame: Visit 2 and 3 ]Compare results of renal plasma flow derived from [I-123]-OIH and [Tc-99m]-MAG3 gamma camera images of healthy prospective kidney donors and patients with stable chronic renal impairment.
- Qualitative Assessment [ Time Frame: Visit 2 and 3 ]Compare the qualitative assessment of kidney uptake, urine excretion and image quality of [I-123]-OIH and [Tc-99m]-MAG3 in an independent read by two nuclear medicine physicians blinded to all participant clinical data.
- Image-derived Perfusion Data [ Time Frame: Visits 2 and 3 ]Compare results of differential perfusion(from image-derived perfusion data) of [I-123]-OIH and [Tc-99m]-MAG3.
- eRPF [ Time Frame: Visits 2 and 3 ]Compare results of effective renal plasma flow (eRPF), using the single sample clearance method of [I-123]-OIH and [Tc-99m]-MAG3.
Biospecimen Retention: None Retained
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496391
|St. Joesph's Healthcare Hamilton|
|Hamilton, Ontario, Canada, L8N 4A6|
|Principal Investigator:||Karen Gulenchyn, MD||St. Joseph's Healthcare Hamilton|