A Single Centre Open Label Comparison of [I-123]-Ortho-Iodohippuric Acid (OIH) With [Tc-99m]-Mercaptoacetyltriglycine (MAG3) for Assessment of Renal Tubular Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Compare kidney function using [I-123]-OIH and [Tc-99m]-MAG3 imaging
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age.
- •Provide signed informed consent.
- •Documented stable renal impairment with an eGFR < 60/mL/min/1.73m^2 by two eGFR measurements within 3 months that are within ± 15% of each other or healthy prospective kidney donor with an eGFR ≥ 60 mL/min/1.73m^2.
排除标准
- •Females who are pregnant, planning to become pregnant or are lactating.
- •Clinically relevant abnormal findings that could, in the opinion of the investigator, interfere with the safe completion of the study.
- •Unable, in the opinion of the clinician or investigator, to tolerate fluid intake required for radionuclide renography.
- •Participation in any clinical trial involving an investigational product within 30 days prior to the first injection.
- •Not using an adequate method of family planning unless the participant, or the male participant's partner, has had a hysterectomy, a tubal ligation, is postmenopausal or is not at risk of pregnancy.
- •Unable to lie still in a supine position for at least 30 minutes.
- •Unable to complete study procedures, including follow-up safety assessments.
- •Medical or psychological conditions that on assessment by the principal investigator make the participant unable to complete the procedure.
- •History of allergic reaction to iodine or iodine compounds, inclusive of iodinated x-ray contrast media.
- •Any other conditions that may impact the participant's ability to complete the study.
结局指标
主要结局
Compare kidney function using [I-123]-OIH and [Tc-99m]-MAG3 imaging
时间窗: 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.
[I-123]-OIH Safety
时间窗: 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.
次要结局
- Image-derived Perfusion Data(Visits 2 and 3)
- eRPF(Visits 2 and 3)
- Qualitative Assessment(Visit 2 and 3)