Dual Headed CZT Breast Imager

双头 CZT 乳房成像仪

• 批准号: 7277110
• 负责人: Douglas J. Wagenaar
• 金额: $ 20.2万
• 依托单位: GAMMA MEDICA-IDEAS, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-30 至 2008-08-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7277110
• 关键词: Algorithms; Biopsy; Breast; Breast Cancer Detection; Breast Cancer Treatment; Cadmium; Categories; Characteristics; Clinic; Clinical; Clinical Research; Collimator; Computer software; Condition; DMSA; Data; Detection; Development; Devices; Diagnosis; Diagnostic; Early Diagnosis; Evaluation; Feasibility Studies; Gamma Cameras; Goals; Head; Hospitals; Image; Image Analysis; Imaging Device; Isotopes; Kinetics; Lesion; Los Angeles; Magnetic Resonance Imaging; Mammary Gland Parenchyma; Mammary Neoplasms; Mammography; Medical center; Molecular; Monitor; Noninfiltrating Intraductal Carcinoma; Operative Surgical Procedures; Outcome; Patients; Phase; Pilot Projects; Placement; Process; Property; Protocols documentation; Purpose; Radioactive; Radiopharmaceuticals; Relative (related person); Resolution; Site; Small Business Technology Transfer Research; System; Technetium 99m; Technetium Tc 99m Sestamibi; Testing; Tumor-Associated Process; Validation; Zinc; base; breast lesion; cadmium telluride; clinical research site; design; detector; in vivo; malignant breast neoplasm; novel; pre-clinical; pre-clinical research; programs; prototype; research clinical testing; research study; size; software systems; technetium Tc 99m glucarate; tool; tumor; uptake

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.

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和有限的试点以及临床前和临床研究的临床可行性评价。我们的主要目的是促进证明这种新型成像设备用于乳腺癌早期检测、诊断和治疗监测的可行性。该成像系统的目的是使用既有的放射性标记物和新的放射性标记物在分子水平上确定乳腺癌的特征，从而能够早期检测和监测乳腺癌的治疗。该系统的新奇有两个方面：1）开发了一种系统，该系统将在专用机架中包括两个相对的碲锌镉（CZT）半导体探测器，以及2）开发了算法和相应的临床软件包，这些软件包将允许对放射性药物的肿瘤摄取进行绝对定量，并允许监测乳腺组织中放射性药物的摄取和清除动力学。我们在此Fast Track STTR提案中的主要目标是创建临床工具、双头乳腺成像系统（将由GM开发）和用于功能性乳腺成像的图像数据定量分析软件（马约）。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。每个机构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中的潜在应用。在此快速通道STTR的第一阶段，我们将构建一个功能齐全的双头CZT乳腺成像相机，包括采集、处理、肿瘤定量和同步双同位素功能。第一阶段将建造一台经过测试的原型相机，第二阶段将建造另外两台相机，以模拟原始相机，并进行组装。在本提案的第二阶段，主要目标是评价双头乳腺成像系统（将由GM开发）和图像数据定量分析软件（将由马约开发）的临床实用性。这将通过一项多中心初步研究来完成。三家临床试验机构将进行一项患者研究，以确认该器械检测10 mm以下乳腺病变的能力。次要目的是：1）比较该器械与MRI的诊断能力，2）探索该器械在双同位素研究中的潜在应用，3）证明其评价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研究中心进行。