Dual Headed CZT Breast Imager

描述（由申请人提供）：本提案的重点是开发一种新型体内成像设备（分子乳腺成像系统），该设备包括临床验证实验、有限的试点和临床前和临床研究的临床可行性评估。我们的主要目的是促进证明这种新型成像设备在乳腺癌早期检测、诊断和治疗监测方面的可行性。该成像系统的目的是在分子水平上使用现有的和新的放射性标记物来定义乳腺癌的特征，这些标记物可以使乳腺癌的早期发现和监测治疗成为可能。该系统的新颖之处在于两个方面：1)开发了一个系统，该系统将包括两个相对的碲化镉锌（CZT）半导体探测器，在一个专门的龙门架中；2)开发了算法和相应的临床软件包，可以对肿瘤对放射性药物的摄取进行绝对定量，并允许监测放射性药物在乳腺组织中的摄取和洗脱动力学。我们在快速通道STTR提案中的主要目标是创建临床工具，双头乳房成像系统（将由GM开发）和用于功能性乳房成像图像数据定量分析的软件（Mayo）。我们的第二个目标是证明相机作为临床前研究设备的能力。每个设施将完成小型患者试验，以说明该设备和相关软件在评估用于检测乳腺癌的新放射性药物方面的潜在应用。在这个快速通道STTR的第一阶段，我们将构建一个功能齐全的双头CZT乳房成像相机，具有采集、处理、肿瘤量化和同步双同位素功能。在第一阶段将建造一个经过测试的原型相机，另外两个相机将模拟原始相机，并将在第二阶段进行组装。在该提案的第二阶段，主要目标是评估双头乳房成像系统（将由GM开发）和图像数据定量分析软件（将由Mayo开发）的临床实用性。这将通过多中心试点研究来完成。三个站点将进行患者研究，以验证该设备检测10毫米以下乳房病变的能力。次要目标是1)比较该设备与MRI的诊断能力，2)探索该设备在双同位素研究中的潜在应用，以及3)证明其评估新的有前途的放射性药物的能力。次要目标将在II期完成，并将在所有三个临床站点进行。

DESCRIPTION (provided by applicant): The focus of this proposal is the development of a novel in-vivo imaging device (Molecular Breast Imaging system) that incorporates a clinical validation experiment and a limited pilot and a clinical feasibility evaluation for pre-clinical and clinical studies. Our primary intent is to facilitate the proof of feasibility of this novel imaging device for early detection, diagnosis, and treatment monitoring of breast cancer. The purpose of this imaging system is to define the characteristics of breast cancer at a molecular level using both established and novel radioactive markers that can enable the early detection and monitor the treatment of breast cancer. The novelty of this system is two fold: 1) development of a system that will comprise two opposing Cadmium Zinc Telluride (CZT) semi-conductor detectors in a specialized gantry, and 2) development of algorithms and corresponding clinical software packages that will permit absolute quantitation of tumor uptake of radiopharmaceuticals and permit monitoring of the kinetics of uptake and washout of radiopharmaceuticals in breast tissue. It is our primary goal in this Fast Track STTR proposal to create clinical tools, dual-headed breast imaging system (to be developed by GM) and software for quantitative analysis of the image data (Mayo) for functional breast imaging. Our secondary goal is demonstrate the ability of the camera to be utilized as a preclinical research device. Each facility will complete small patient trials to illustrate the potential application of this device and associated software in the evaluation of new radiopharmaceuticals for detection of breast cancer. During the Phase I of this Fast Track STTR we will construct a fully functional Dual Headed CZT breast imaging camera complete with Acquisition, Processing, Tumor Quantification, and simultaneous dual Isotope Capabilities. One tested prototype camera will be built during Phase-I and two additional cameras will emulate the original and their assembly will take place during Phase-II. During Phase-II of this proposal the primary goal is to evaluate the clinically usefulness of a dual-headed breast imaging system (to be developed by GM) and software for quantitative analysis of the image data (to be developed by Mayo). This will be accomplished through a multi-center pilot study. Three sites will conduct a patient study that will validate the ability of this device to detect sub-10 mm breast lesions. The secondary goals are 1) to compare the diagnostic capabilities of this device to MRI, 2) to explore the potential application of this device in dual-isotope studies, and 3) to demonstrate its ability to evaluate new promising radiopharmaceuticals. The secondary goals will be accomplished during Phase II and will be undertaken at all three clinical sites.