Photoacoustic Needle for Identifying Tumor Content and Margins to Improve Sampling During Core Needle Biopsy

肿瘤活检中动态生物标记物的分析正在以越来越频繁的频率进行，以帮助医生诊断、选择和评估治疗方法以及了解疾病复发。目前的活检技术是为了获得具有足够数量的恶性细胞的标本，以进行组织病理学诊断。然而，病理分析所需的活检标本的肿瘤含量远远低于低流行突变的分子图谱或生物标记物定量所需的含量，这将有助于确定患者的治疗方案。这项第二阶段的SBIR将最终完成PSITE(识别肿瘤边缘的光声系统)的开发，并将在体内两个大型动物自发肿瘤模型中展示使用该技术收集的核心针刺活检(CNB)样本的改进的诊断潜力。根据第二阶段的合同，承包商将继续推进第一阶段展示的PSITE光声(PA)技术，方法是生产一个现场就绪的原型，其中包括优化的设备设计和性能，并建立生产文件和方法，以实现该系统的商业化。将进行具有显著统计能力的脊椎动物研究，以证明PSITE的安全性和有效性，包括一项适合用途的临床犬研究，该研究将为FDA为下一阶段人类临床研究确定非重大风险(NSR)分类提供数据。

Analysis of dynamic biomarkers in tumor biopsies is being performed with increasing frequency to help physicians in diagnosis, selecting and assessing treatment, and understanding disease recurrence. Current biopsy techniques were developed to acquire specimens with sufficient numbers of malignant cells for histopathologic diagnosis. However, the tumor content of a biopsy specimen required for pathological analysis is much lower than what is required for molecular profiling of low prevalence mutations or biomarker quantification, which would aid in determining therapeutic options for the patient. This Phase II SBIR will finalize the development of the PSITE – Photoacoustic System Identifying Tumor Edges – and will demonstrate the improved diagnostic potential of core needle biopsy (CNB) samples collected using this technology in two large-animal, spontaneous tumor models in vivo. Under the Phase II contract, the contractor will continue progression of the PSITE photoacoustic (PA) technology demonstrated in Phase I, by producing a field-ready prototype that incorporates an optimized device design and performance, and establishment of production documentation and methods towards commercialization of the system. Vertebrate animal studies with significant statistical power will be performed to demonstrate both safety and efficacy of the PSITE, including a fit-for-purpose clinical canine study that will provide data towards determination of a Non-Significant Risk (NSR) classification from the FDA for next-stage human clinical studies.