Dual-Tracer PET Tumor Imaging

摘要 使用18F-氟脱氧葡萄糖的正电子发射断层扫描（PET，包括PET/CT和PET/MRI） (FDG)在各种恶性肿瘤的诊断和分期，评估肿瘤的 等级，并评估对治疗的反应。最近批准的其他示踪剂的出现，特别是 那些有治疗诊断学合作伙伴的人，正在开启一个新的成像时代，在这个时代，PET示踪剂的摄取可以 直接预测某些靶向治疗的有效性。这种治疗诊断示踪剂成像不同 在肿瘤功能方面比传统的诊断示踪剂（例如FDG），它们提供了互补的 在不同肿瘤分化水平上具有不同检测和分期性能的图像， 年级在每个患者中常规成像多个PET示踪剂的能力将提供增加的 诊断性能，改进分级和分期信息，并结合联合收割机预测治疗诊断 影像学检查和诊断检查。然而，目前的技术要求单独的扫描被 通常在不同的日子为每个示踪剂进行，导致高成本、调度和后勤 #21453;，给患者带来不必要的负担。我们建议通过快速开发来消除这些障碍， 双示踪剂PET肿瘤成像技术-在单次扫描中提供两种PET示踪剂的准确图像， 并使这些技术可用于一般临床应用。多功能成像有限责任公司（MFI） 之前开发了一种软件医疗设备mfiVerse™，可实现单次扫描休息+压力 心肌灌注PET成像。这个SBIR项目将扩展软件的功能， 支持双示踪剂PET癌症成像--一组更广泛的应用， 临床需要。我们将首先开发FDG和Ga68 DOTATATE成像的能力， 示踪剂PET检查，这将为分化良好和分化不良的患者提供更好的成像性能 神经内分泌肿瘤，并同时预测对Lu 177靶向放射性核素治疗的反应 DOTATATE。这个第一阶段的项目将建立一个完全工作的原型双示踪PET肿瘤 成像，建立其初始运行性能，并为全面的产品开发奠定基础， 在随后的第二阶段项目下进行验证。该设备还将扩展到支持其他示踪剂 第二阶段的组合。该项目的完成将创造一个第一个同类设备的双示踪剂 癌症PET成像，使双示踪剂PET能够常规用于各种癌症成像 迹象。

Abstract Positron emission tomography (PET, including PET/CT and PET/MRI) with 18F-fluorodeoxyglucose (FDG) plays a key role in diagnosing and staging a wide variety of malignant tumors, assessing tumor grade, and evaluating response to therapy. The advent of other recently approved tracers, particularly those with theranostic partners, is opening a new era of imaging where the uptake of PET tracers can directly predict the effectiveness of certain targeted therapies. Such theranostic tracers image different aspects of tumor function than traditional diagnostic tracers (e.g. FDG), and they provide complementary images with different detection and staging performance across different levels of tumor differentiation and grade. The ability to routinely image multiple PET tracers in each patient would provide increased diagnostic performance, improved grading and staging information, and combine predictive theranostic imaging with the diagnostic workup. However, current technology requires that separate scans be performed for each tracer—usually on separate days—resulting in high cost, scheduling and logistical challenges, and undue burden on the patient. We propose to remove these obstacles by developing rapid dual-tracer PET tumor imaging techniques—providing accurate images of two PET tracers in a single scan, and making these techniques available for general clinical use. Multifunctional Imaging LLC (MFI) has previously developed a software medical device, mfiVerse™, which enables single-scan rest+stress myocardial perfusion PET imaging. This SBIR project will expand the software's capabilities to also support dual-tracer PET cancer imaging—a much broader set of applications that will serve many more clinical needs. We will first develop the capability to image FDG and Ga68 DOTATATE in a single, dual- tracer PET exam, which will provide improved imaging performance for both well- and poorly-differentiated neuroendocrine tumors, and simultaneously predict response to targeted radionuclide therapy with Lu177 DOTATATE. This Phase I project will establish a fully working prototype for dual-tracer PET tumor imaging, establish its initial operating performance, and set the stage for full product development and validation under a subsequent Phase II project. The device will also be expanded to support other tracer combinations in Phase II. Completion of this project will create a first-of-its-kind device for dual-tracer cancer PET imaging, enabling routine use of dual-tracer PET for a wide variety of cancer imaging indications.