Discrete Sensor Devices for Determining Cancer Targets

用于确定癌症目标的分立传感器设备

基本信息

批准号：
8722465
负责人：
Michael J Cima
金额：
$ 18.83万
依托单位：
MASSACHUSETTS INSTITUTE OF TECHNOLOGY
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至 2016-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8722465
关键词：
A Mouse Address Affect Animal Model Animals Attention Behavior Biological Biopsy Cancer Center Cancer Model Canis familiaris Cell Line Clinical Clinical Trials Collaborations Data Detection Development Devices Dimensions Environment Exhibits Future Gel Goals Human Hypoxia Immigration Implant Implantation procedure In Situ In Vitro Injectable Injection of therapeutic agent Laboratories Magnetic Resonance Magnetic Resonance Imaging Malignant Neoplasms Malignant neoplasm of cervix uteri Measurement Methods Microspheres Modeling Monitor Mus Nanotechnology Needle biopsy procedure Oncologist Operative Surgical Procedures Oxygen Procedures Reading Shapes Side Site Technology Testing Time Toxic effect Treatment Efficacy Validation cancer therapy chemotherapy clinical care clinical practice commercialization cost design implantable device implanted sensor improved in vitro testing in vivo in vivo Model irradiation melanoma minimally invasive model design mouse model new technology non-invasive monitor novel novel strategies operation pre-clinical preclinical efficacy preclinical study prevent research study response screening sensor subcutaneous tool treatment response tumor uptake

项目摘要

The long-term objective of this project is to bring to clinical practice a novel technology for the real-time and non-invasive measurement of cancer-related analytes. This technology consists of a sensor implanted at the time of a tumor biopsy to allow subsequent monitoring of tumor analytes such as pH and p02 through magnetic resonance methods. The specific aims of the project are as follows: design and execute preclinical studies in support of a Premarl<et Approval Application to the FDA, and develop a new approach to construction of the sensors. Sensors will first be validated in a mouse model designed to show differential response to chemotherapy for the pH sensor, and temporal response to irradiation in the case of the p02 sensor. These models will allow the correlation of sensor measurements to therapeutic efficacy in mice and provide in vivo validation of the devices. A preclinical study in dogs with endogenous tumors will then follow to test the devices in actual canine subjects, a particularly important step given that canine tumor models exhibit biological behavior similar to human cancers. Results from these studies will provide supporting evidence for a Premarket Approval Application to the FDA. The second aim in this project is the development of two minimally-invasive sensor formats with reduced dimensions compared to the current sensor size. Each of these formats will afford a different advantage to the device. The biopsy-implantable sensor, fitted with a coil, will allow reading of the device without the use of a costly MRI scanner, while the injectable sensor will simplify the implantation procedure ofthe device, without requiring surgery or a biopsy. The biopsy-implantable sensor will be validated in vitro and in vivo by pH measurements with a benchtop one-sided NMR, using the mouse model developed forthe first specific aim. The injectable sensor will consist of 3 parts which may be investigated concurrently: fabrication of semi-permeable microspheres containing the sensing agent; development ofthe injectable device matrix; and in situ control ofthe size and shape of the device. The device will be validated in vitro and in vivo similarly to the biopsy-implantable sensor.

该项目的长期目标是为临床实践带来一种新型技术，用于对癌症相关分析物的实时和非侵入性测量。该技术由在肿瘤活检时植入的传感器组成，可通过磁共振方法随后监测肿瘤分析物，例如pH和P02。该项目的具体目的如下：设计和执行临床前研究以支持FDA的Premarl <et批准应用，并开发了一种新的传感器构建方法。传感器将首先在旨在显示对pH传感器化学疗法的差异反应的小鼠模型中进行验证，并在P02传感器的情况下对照射的时间响应。这些模型将允许传感器测量与小鼠的治疗功效相关，并提供对设备的体内验证。然后，在具有内源性肿瘤的狗的临床前研究将跟随实际犬科受试者中的设备，这是犬肿瘤模型的特别重要步骤表现出类似于人类癌的生物行为。这些研究的结果将为FDA提供前市场批准申请的证据。该项目的第二个目的是开发两种最小侵入性传感器格式，与当前传感器尺寸相比，尺寸降低了。这些格式中的每一种都将为设备带来不同的优势。装有线圈的活检 - 植入传感器将允许在不使用昂贵的MRI扫描仪的情况下读取设备，而注射的传感器将简化设备的植入程序，而无需手术或活检。使用为第一个特定目的开发的小鼠模型，使用台式单侧NMR pH测量将在体外和体内验证活检 - 可植入传感器。注射传感器将由3个部分组成，可以同时研究：制造含有传感剂的半渗透微球；开发注射设备矩阵；并原位控制设备的尺寸和形状。该设备将在体外和体内验证与活检 - 植入传感器相似。