Novel method to measure glomerular filtration rate

描述(由申请人提供)： 第一阶段测试的假设是，理想的滤过标记物可以用金属标记，当中子被激活时，金属会产生适合测量肾小球滤过率(GFR)的强光子信号。我们成功地验证了我们的假设，并论证了概念的可行性。我们第一阶段研究的结果确定了三种有希望的制剂。我们的第二阶段研究将通过使用活体兔模型将我们的新方法与测量GFR(I-125)和51-Cr-EDTA的传统方法进行直接比较，从而扩展这项工作。此外，第二阶段将评估每种药物的生物分布，并将启动必要的临床前毒理学研究，将该项目推进到LIL阶段。我们的目标是确定一种理想的过滤标记，可以用两种不同的稳定同位素标记。因此，我们可以提供一种安全、易用、准确和经济的非放射性GFR检测试剂盒，同时为广泛的临床和研究应用提供一种通用的诊断方式。

DESCRIPTION (provided by applicant): The hypothesis tested during Phase I was that an ideal filtration marker can be labeled with a metal that when neutron activated generates a strong photon signal suitable for the measurement of glomerular filtration rate (GFR). We successfully proved our hypothesis and demonstrated concept feasibility. The results of our Phase I study have identified three promising agents. Our Phase II research will expand on this work by directly comparing our novel method to traditional methods of measuring GFR (sodium iothalanate (I-125) and 51-Cr-EDTA) using an in vivo rabbit model. In addition, Phase II will evaluate the biodistribution of each agent and will initiate preclinical toxicology studies necessary to carry the project forward to Phase lIl. Our goal is to identify an ideal filtration marker that can be labeled with two different stable isotopes. As a result, we can provide a non-radioactive GFR assay kit that is safe, easy-to-use, accurate, and cost-effective, while providing a diagnostic modality that is versatile for a wide range of clinical and research applications.