IGF::OT::IGF SBIR PHASE I TOPIC 331: DEVELOPMENT OF A PO2 GUIDED CORE NEEDLE TUMOR BIOPSY DEVICE

本研究旨在开发一种与活检针共存的氧传感器，以协助对肿瘤细胞进行活检，以进行低流行突变的分子谱分析或生物标志物量化，并允许实时绘制尸检和复生的复杂区域。肿瘤可以有大面积的坏死组织和小范围的活肿瘤细胞，也可以有大面积的活肿瘤和小范围的坏死组织。活检设备将为临床医生提供调查和绘制可疑组织所需的分辨率。特别是，活检设备将：1)确保对肿瘤的活的（活的）部分进行采样，2)为临床医生提供整个肿瘤的氧气水平，以帮助选择最有效的治疗方法，3)在选择治疗期间帮助预测临床结果。在氧分压（pO2）引导下，真空辅助针头将允许对不同缺氧水平的组织进行多次小体积活检，以获得更可靠的诊断。MDA231人乳腺癌小鼠模型将使用CT扫描成像来评估和演示该装置，以放置针/传感器尖端。马萨诸塞大学医学院将协助动物研究和组织学研究。

This research intends to develop an oxygen sensor co-located with a biopsy needle to assist in the biopsy of tumor cells for molecular profiling of low-prevalence mutations or biomarker quantification and to permit real-time mapping of complex areas of necropsy and metathesis. Tumors can have large regions of necrotic tissue with small peripheral areas of live tumor cells or large viable tumors with small areas of necrotic tissue on the periphery. The biopsy device will provide the clinician with the resolution needed to survey and map the suspect tissue. In particular, the biopsy device will: 1) Assure sampling of viable (living) parts of a tumor, 2) Provide clinicians with oxygen levels throughout the tumor to aid in choosing the most effective treatment therapies, 3) Aid in predicting clinical outcomes during selected therapies. Partial pressure of oxygen (pO2)-guided, vacuum-assisted needles will permit the collection of multiple small-volume biopsies of tissue with different levels of hypoxia for more reliable diagnosis. A mouse model with MDA231 human breast carcinoma will be used to evaluate and demonstrate the device using CT scan imaging to place the needle/sensor tip. The University of Massachusetts Medical School will assist with the animal studies and histology.