Proceduralist criteria for evaluating interface utility of novel imaging modalities in early phase clinical trials: evaluating the need for standardized criteria.
Proceduralist criteria for evaluating interface utility of novel imaging modalities in early phase clinical trials: evaluating the need for standardized criteria.
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评估早期临床试验中新型成像方式的界面实用性的程序主义标准：评估标准化标准的必要性。
DOI：
10.1117/12.2650756
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发表时间：
2023
期刊：
影响因子：
--
通讯作者：
Singhal,Sunil
中科院分区：
文献类型：
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作者：
Henderson,EricR;Elliott,Jonathan;Jiang,Shudong;Gitajn,ILeah;Lee,John;Gibbs,Summer;Bouvet,Michael;Mahadevan-Jansen,Anita;Daly,Michael;Streeter,SamuelS;Paulsen,KeithD;Pogue,BrianW;Samkoe,KimberleyS;Singhal,Sunil
在手术应用的荧光成像领域加速创新，增加了人们对通过符合美国食品药品监督管理局（FDA）标准的试验将这些技术安全便捷地推向临床的兴趣。早期试验的常规指标包括药物安全性、耐受性、剂量和药代动力学。大多数程序成像技术依赖于外源性荧光团的管理和成像系统的同时使用;两者都必须获得FDA批准才能进入临床。由于荧光团被归类为医学成像剂，因此确定剂量的标准与治疗药物不同，并且可以说更复杂。由于不需要治疗效果，因此理想地以实现充分靶向区分的最低剂量施用医学成像剂。由于手术成像模式旨在增强和/或简化手术医师对组织的识别或评估，因此这些技术的有益效果可能以定性终点的形式表现出来，例如：1）置信度; 2）决策;以及3）对指定手术的满意度。由于医学成像技术的快速发展，我们认为我们的领域需要标准化的标准来客观地评估现有和新兴技术，以便可以测量其使用的定量和定性方面，并进行有用的比较以评估其相对价值。在这里，我们提出了一个15项共识为基础的调查工具，以评估新的成像技术的实用程序的立场。
Accelerating innovation in the space of fluorescence imaging for surgical applications has increased interest in safely and expediently advancing these technologies to clinic through Food and Drug Administration-(FDA-) compliant trials. Conventional metrics for early phase trials include drug safety, tolerability, dosing, and pharmacokinetics. Most procedural imaging technologies rely on administration of an exogenous fluorophore and concurrent use of an imaging system; both of which must receive FDA approval to proceed to clinic. Because fluorophores are classified as medical imaging agents, criteria for establishing dose are different, and arguably more complicated, than therapeutic drugs. Since no therapeutic effect is desired, medical imaging agents are ideally administered at the lowest dose that achieves adequate target differentiation. Because procedural imaging modalities are intended to enhance and/or ease proceduralists’ identification or assessment of tissues, beneficial effects of these technologies may manifest in the form of qualitative endpoints such as: 1) confidence; 2) decision-making; and 3) satisfaction with the specified procedure. Due to the rapid expansion of medical imaging technologies, we believe that our field requires standardized criteria to evaluate existing and emerging technologies objectively so that both quantitative and qualitative aspects of their use may be measured and useful comparisons to assess their relative value may occur. Here, we present a 15-item consensus-based survey instrument to assess the utility of novel imaging technologies from the proceduralist’s standpoint.