Dual-Tracer PET Tumor Imaging

摘要 18F-氟代脱氧葡萄糖正电子发射断层扫描(PET) 脱氧葡萄糖(FDG)在多种恶性肿瘤的诊断和分期、评估肿瘤等方面起着关键作用 分级，并评估治疗反应。最近批准的其他示踪剂的出现，特别是 那些有治疗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效果。这样的声学示踪剂图像不同 与传统的诊断示踪剂(如FDG)相比，它们在肿瘤功能方面具有互补性 在不同级别的肿瘤分化和分期中具有不同检测和分期性能的图像 年级。在每个患者身上常规成像多个PET示踪剂的能力将提供更多 诊断性能，改进的分级和分期信息，并结合预测性治疗 诊断检查中的影像检查。然而，目前的技术要求单独扫描 为每个示踪剂执行--通常在不同的日子--导致高成本、高进度和高后勤 挑战，给病人带来不必要的负担。该项目将通过开发 同步双示踪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用途。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mfiVerseä，它可以实现休息和压力 心肌灌注PET图像可在短短15分钟内单次扫描获得。这个SBIR项目 将扩展软件功能以支持双示踪PET癌症成像-更广泛的设置 的应用程序将服务于更多的临床需求，并显著增加市场对此的需求 产品。FDG+DOTATE和FDG+PSMA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+DOTATE的联合成像将有所改进 高分化和低分化神经内分泌肿瘤的影像表现 同时预测Lu177 DOTATE靶向放射性核素治疗的反应。同样， 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，同时预测靶向放射性核素治疗的反应 Lu177 PSMA。这一第二阶段项目将完成新的双示踪技术的开发和 在一项对60名前列腺癌或NETS患者进行的前瞻性临床研究中对其进行彻底评估，获得 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首个用于同时进行双示踪PET的医疗设备 成像，在随后的监管批准后，将使双示踪PET的常规临床使用成为可能 肿瘤成像，以提高前列腺癌或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，提供 改进对广泛癌症人群的诊断评估和图像指导的治疗选择 病人。

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.