Quantitative Ultrasound Analysis of Vascular Morphology for Cancer Assessment

 描述（由申请人提供）：超声成像的几个特点使其对临床医生和临床前研究人员具有吸引力，包括其相对较低的成本、实时成像能力、安全性和便携性。例如，超声成像广泛用于心脏和大血管中的解剖成像和血流测量。然而，超声通常不用于肿瘤学，因为其相对于肿瘤形态或恶性程度具有相对差的定量能力。在我们的第一阶段工作中，我们证明了我们新的对比增强双频超声技术（“声学血管造影”）可以在乳腺癌动物模型中捕获组织血管的详细体内图像，并且我们已经证明血管形态是这些动物模型中肿瘤恶性程度的指标。这项工作建立在我们之前的血管分析研究和算法的基础上，这些研究和算法表明，来自磁共振成像数据的可量化血管形态指标是人类肿瘤恶性程度和治疗反应的可靠预测指标。在拟议的第二阶段工作中，我们将进行必要的研究，使我们的声学血管造影系统的商业化，用于临床前研究。该团队已扩大到包括Sonopolitan，用于临床前研究的超声系统制造商。我们将研究和评估方法，以确保我们的商业系统易于使用，并持续产生肿瘤恶性程度和治疗反应的有效措施。我们将在乳腺癌治疗功效的盲法研究中验证该产品，以支持临床前试验，即，建议系统的目标商业用途。

 DESCRIPTION (provided by applicant): There are several features of ultrasound imaging that make it attractive to clinicians and preclinical researchers, including its relatively low cost, rel-time imaging capability, safety, and portability. For example, ultrasound imaging is widely used for anatomical imaging and blood flow measurements in the heart and large vessels. Ultrasound, however, is typically not used in oncology because it has relatively poor quantitative capability with respect to tumor morphology or malignancy. In our Phase I work, we demonstrated that our new contrast-enhanced dual-frequency ultrasound technologies ("Acoustic Angiography") can capture detailed in vivo images of tissue vasculature in animal models of breast cancer, and we have shown that vascular morphology is an indicator of tumor malignancy in those animal models. That work built upon our prior vessel analysis research and algorithms that showed that quantifiable vascular morphology metrics from Magnetic Resonance Imaging data are reliable predictors of tumor malignancy and response to therapy in humans. In the proposed Phase II work, we will conduct the research necessary for the commercialization of our acoustic angiography system for preclinical research. The team has been expanded to include SonoVol, the manufacturer of ultrasound systems for preclinical research. We will research and evaluate methods to ensure that our commercial system will be easy to use and consistently produce effective measures of tumor malignancy and response to therapy. We will validate the product in a blinded study of breast cancer treatment efficacy in support of a preclinical trial, i.e., the targeted commercial use for the proposed system.