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| Name | Class |
|---|---|
| McMaster University | OTHER |
| St. Joseph's Healthcare Hamilton | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Participants | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| [I-123]-OIH Safety | 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. | Visit 3 and Follow-up Phone Call |
| Compare kidney function using [I-123]-OIH and [Tc-99m]-MAG3 imaging | 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. | Visit 2 and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Assessment | 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. | Visit 2 and 3 |
| Image-derived Perfusion Data |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be recruited from both healthy subjects (eGFR ≥ 60 mL/minute/1.73m^2) being assessed as potential renal donors and patients having suspected renal impairment (eGFR <60 mL/minute/1.73m^2). Severity of disease will be determined based on estimated glomerular filtration rate (eGFR) derived from serum creatinine concentration.
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| Name | Affiliation | Role |
|---|---|---|
| Karen Gulenchyn, MD | St. Joseph's Healthcare Hamilton | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joesph's Healthcare Hamilton | Hamilton | Ontario | L8N 4A6 | Canada |
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Whole blood (chemistry, hematology) and kidney function (eGRF, eRPF)
Compare results of differential perfusion(from image-derived perfusion data) of [I-123]-OIH and [Tc-99m]-MAG3. |
| Visits 2 and 3 |
| eRPF | Compare results of effective renal plasma flow (eRPF), using the single sample clearance method of [I-123]-OIH and [Tc-99m]-MAG3. | Visits 2 and 3 |