Siegel J A, Thomas S R, Stubbs J B, Stabin M G, Hays M T, Koral K F, Robertson J S, Howell R W, Wessels B W, Fisher D R, Weber D A, Brill A B
Nuclear Physics Enterprises, Cherry Hill, New Jersey, USA.
J Nucl Med. 1999 Feb;40(2):37S-61S.
This report describes recommended techniques for radiopharmaceutical biodistribution data acquisition and analysis in human subjects to estimate radiation absorbed dose using the Medical Internal Radiation Dose (MIRD) schema. The document has been prepared in a format to address two audiences: individuals with a primary interest in designing clinical trials who are not experts in dosimetry and individuals with extensive experience with dosimetry-based protocols and calculational methodology. For the first group, the general concepts involved in biodistribution data acquisition are presented, with guidance provided for the number of measurements (data points) required. For those with expertise in dosimetry, highlighted sections, examples and appendices have been included to provide calculational details, as well as references, for the techniques involved. This document is intended also to serve as a guide for the investigator in choosing the appropriate methodologies when acquiring and preparing product data for review by national regulatory agencies. The emphasis is on planar imaging techniques commonly available in most nuclear medicine departments and laboratories. The measurement of the biodistribution of radiopharmaceuticals is an important aspect in calculating absorbed dose from internally deposited radionuclides. Three phases are presented: data collection, data analysis and data processing. In the first phase, data collection, the identification of source regions, the determination of their appropriate temporal sampling and the acquisition of data are discussed. In the second phase, quantitative measurement techniques involving imaging by planar scintillation camera, SPECT and PET for the calculation of activity in source regions as a function of time are discussed. In addition, nonimaging measurement techniques, including external radiation monitoring, tissue-sample counting (blood and biopsy) and excreta counting are also considered. The third phase, data processing, involves curve-fitting techniques to integrate the source time-activity curves (determining the area under these curves). For some applications, compartmental modeling procedures may be used. Last, appendices are included that provide a table of symbols and definitions, a checklist for study protocol design, example formats for quantitative imaging protocols, temporal sampling error analysis techniques and selected calculational examples. The utilization of the presented approach should aid in the standardization of protocol design for collecting kinetic data and in the calculation of absorbed dose estimates.
本报告描述了在人体受试者中获取和分析放射性药物生物分布数据以使用医学内照射剂量（MIRD）模式估算辐射吸收剂量的推荐技术。该文件采用了一种格式，面向两类受众：对设计临床试验感兴趣但不是剂量学专家的个人，以及在基于剂量学的方案和计算方法方面有丰富经验的个人。对于第一类人群，介绍了生物分布数据采集所涉及的一般概念，并为所需测量次数（数据点）提供了指导。对于剂量学方面的专家，包含了突出显示的部分、示例和附录，以提供所涉及技术的计算细节以及参考文献。本文件还旨在为研究人员在获取和准备产品数据以供国家监管机构审查时选择合适的方法提供指导。重点是大多数核医学科室和实验室中常见的平面成像技术。放射性药物生物分布的测量是计算体内沉积放射性核素吸收剂量的一个重要方面。文中介绍了三个阶段：数据收集、数据分析和数据处理。在第一阶段，即数据收集阶段，讨论了源区域的识别、其适当时间采样的确定以及数据的获取。在第二阶段，讨论了涉及通过平面闪烁相机、单光子发射计算机断层扫描（SPECT）和正电子发射断层扫描（PET）成像以计算源区域活性随时间变化的定量测量技术。此外，还考虑了非成像测量技术，包括外部辐射监测、组织样本计数（血液和活检）以及排泄物计数。第三阶段，即数据处理，涉及曲线拟合技术以整合源时间 - 活性曲线（确定这些曲线下的面积）。对于某些应用，可使用房室模型程序。最后，附录中提供了符号和定义表、研究方案设计检查表、定量成像方案的示例格式、时间采样误差分析技术以及选定的计算示例。采用所介绍的方法应有助于规范收集动力学数据的方案设计以及吸收剂量估计的计算。
