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。该项目将通过开发 同步双示踪剂PET肿瘤成像技术-提供两种PET示踪剂的准确图像， 一次扫描，并使这些技术可用于一般临床使用。多功能成像有限公司 (MFI)此前开发了一种软件医疗设备mfiVerseä， 心肌灌注PET图像在单次扫描中获得，仅需15分钟。该SBIR项目 将扩展软件功能，以支持双示踪剂PET癌症成像-范围更广 这些应用将服务于更多的临床需求，并显着增加市场需求。 产品FDG+DOTATATE和FDG+PSMA等示踪剂同时成像的新技术 在一个单一的，双示踪PET扫描将被开发。FDG+DOTATATE的联合成像将改善 高分化和低分化神经内分泌肿瘤（NETs）的成像性能， 同时预测对Lu 177 DOTATATE靶向放射性核素治疗的反应。同样地， FDG+PSMA的联合成像将改善高分化和低分化的特征。 前列腺癌肿瘤，同时预测对靶向放射性核素治疗的反应， Lu177 PSMA。第二阶段项目将完成新的双示踪剂技术的开发， 在60例前列腺癌或NETs患者的前瞻性临床研究中彻底评估它， 证明该方法的安全性和有效性所需的所有验证和确认数据。 该项目的完成将创造一个首个用于同时双示踪PET的医疗设备 在随后的监管批准后，将使双示踪剂PET的常规临床使用成为可能 肿瘤成像，以改善前列腺癌或NETs患者的诊断评估。未来 增强功能将扩展对其他示踪剂组合和成像适应症的支持， 改善对广泛癌症人群的诊断评估和影像引导的治疗选择 患者

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. This project will remove those obstacles by developing simultaneous 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, mfiVerseä, which enables both rest and stress myocardial perfusion PET images to be obtained in a single scan in as little at 15 min. This SBIR project will expand the software capabilities to also support dual-tracer PET cancer imaging—a much broader set of applications that will serve many more clinical needs and markedly increase market demand for this product. A new technique for simultaneously imaging tracers such as FDG+DOTATATE and FDG+PSMA in a single, dual-tracer PET scan will be developed. Combined imaging of FDG+DOTATATE will improve imaging performance of both well- and poorly-differentiated neuroendocrine tumors (NETs) while simultaneously predicting response to targeted radionuclide therapy with Lu177 DOTATATE. Similarly, combined imaging of FDG+PSMA will improve characterization of both well- and poorly-differentiated prostate cancer tumors, while at the same time predicting response to targeted radionuclide therapy with Lu177 PSMA. This Phase II project will complete development of the new dual-tracer technique and thoroughly evaluate it in a prospective clinical study of 60 patients with prostate cancer or NETs, acquiring all of the verification and validation data necessary to demonstrate the safety and efficacy of the approach. Completion of this project will create a first-of-its-kind medical device for simultaneous dual-tracer PET imaging which, after subsequent regulatory approval, will enable routine clinical use of dual-tracer PET tumor imaging to improve diagnostic evaluation of patients with prostate cancer or NETs. Future enhancements will expand support to other tracer combinations and imaging indications, providing improved diagnostic evaluation and image-guided selection of therapies for a broad population of cancer patients.