A Single Centre Open Label Comparison of [I-123]-Ortho-Iodohippuric Acid (OIH) With [Tc-99m]-Mercaptoacetyltriglycine (MAG3) for Assessment of Renal Tubular Function
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.
Renal Function Impairment
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|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|
- [I-123]-OIH Safety [ Time Frame: Visit 3 and Follow-up Phone Call ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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
Whole blood (chemistry, hematology) and kidney function (eGRF, eRPF)
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
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
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.
|Contact: Angela Besanger||905-525-9140 ext firstname.lastname@example.org|
|St. Joesph's Healthcare Hamilton||Recruiting|
|Hamilton, Ontario, Canada, L8N 4A6|
|Contact: Bharti Gandhi 905-522-1155 ext 32953 email@example.com|
|Contact: Tammy Murray (Back-up) 905-522-1155 ext 35019 firstname.lastname@example.org|
|Principal Investigator: Karen Gulenchyn, MD|
|Sub-Investigator: William Wong-Pack, MD|
|Sub-Investigator: Amit Singnurkar, MD|
|Principal Investigator:||Karen Gulenchyn, MD||St. Joseph's Healthcare Hamilton|