Physikalisch-Technische Bundesanstalt, Berlin, Germany.
Condensed Matter Physics department, Faculty of Sciences, Campus Universitario Río San Pedro s/n, Cádiz, Spain.
Int J Hyperthermia. 2021;38(1):447-460. doi: 10.1080/02656736.2021.1892837.
PURPOSE: The localized heating of magnetic nanoparticles (MNPs) the application of time-varying magnetic fields - a process known as magnetic field hyperthermia (MFH) - can greatly enhance existing options for cancer treatment; but for broad clinical uptake its optimization, reproducibility and safety must be comprehensively proven. As part of this effort, the quantification of MNP heating - characterized by the specific loss power (), measured in W/g, or by the intrinsic loss power (), in Hm/kg - is frequently reported. However, in / measurements to date, the apparatus, the analysis techniques and the field conditions used by different researchers have varied greatly, leading to questions as to the reproducibility of the measurements. MATERIALS AND METHODS: An interlaboratory study (across = 21 European sites) of calorimetry measurements that constitutes a snapshot of the current state-of-the-art within the MFH community has been undertaken. Identical samples of two stable nanoparticle systems were distributed to all participating laboratories. Raw measurement data as well as the results of in-house analysis techniques were collected along with details of the measurement apparatus used. Raw measurement data was further reanalyzed by universal application of the corrected-slope method to examine relative influences of apparatus and results processing. RESULTS: The data show that although there is very good intralaboratory repeatability, the overall interlaboratory measurement accuracy is poor, with the consolidated data having standard deviations on the mean of ca. ± 30% to ± 40%. There is a strong systematic component to the uncertainties, and a clear rank correlation between the measuring laboratory and the . Both of these are indications of a current lack of normalization in this field. A number of possible sources of systematic uncertainties are identified, and means determined to alleviate or minimize them. However, no single dominant factor was identified, and significant work remains to ascertain and remove the remaining uncertainty sources. CONCLUSION: We conclude that the study reveals a current lack of harmonization in MFH characterization of MNPs, and highlights the growing need for standardized, quantitative characterization techniques for this emerging medical technology.
目的:局部加热磁性纳米粒子(MNPs),应用时变磁场 - 这一过程称为磁场热疗(MFH) - 可以极大地增强癌症治疗的现有选择;但是为了广泛的临床应用,必须全面证明其优化、可重复性和安全性。作为这项努力的一部分,经常报告 MNP 加热的量化 - 以特定损耗功率()表示,以 W/g 为单位,或以固有损耗功率()表示,以 Hm/kg 为单位 - 。然而,迄今为止的 / 测量中,不同研究人员使用的仪器、分析技术和场条件变化很大,导致对测量的可重复性产生疑问。
材料和方法:进行了一项涉及 21 个欧洲站点的实验室间研究(跨越 = 21 个欧洲站点),这构成了 MFH 社区当前最新状态的快照。将两种稳定的纳米粒子系统的相同样品分发给所有参与实验室。收集了原始测量数据以及内部分析技术的结果,以及所使用的测量仪器的详细信息。进一步对原始测量数据进行了重新分析,普遍应用了校正斜率法,以检查仪器和结果处理的相对影响。
结果:数据表明,尽管实验室内部的重复性非常好,但总体实验室间测量精度较差,平均标准偏差约为 ± 30%至 ± 40%。不确定性存在很强的系统成分,并且测量实验室和 之间存在明显的等级相关性。这两个都是该领域目前缺乏标准化的迹象。确定了一些可能的系统不确定性源,并确定了减轻或最小化这些不确定性源的方法。然而,没有确定单一的主导因素,仍需要大量工作来确定和消除剩余的不确定性源。
结论:我们的结论是,该研究揭示了 MFH 对 MNPs 特性描述中当前缺乏协调一致的情况,并强调了对这种新兴医疗技术进行标准化、定量特性描述技术的日益增长的需求。
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