Dual Headed CZT Breast Imager

双头 CZT 乳房成像仪

• 批准号: 7678779
• 负责人: Douglas J. Wagenaar
• 金额: $ 86.24万
• 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 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7678779
• 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; abstracting; 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）：该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），该设备结合了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估。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现有的和新型的放射性标记物在分子水平上定义乳腺癌的特征，从而实现乳腺癌的早期检测和监测治疗。该系统的新颖性有两个方面：1) 开发一个系统，该系统将在专门的机架中包含两个相对的碲化镉锌 (CZT) 半导体探测器；2) 开发算法和相应的临床软件包，允许对肿瘤吸收放射性药物进行绝对定量，并允许监测放射性药物的吸收和冲刷动力学。 乳腺组织中的放射性药物。我们在此快速通道 STTR 提案中的主要目标是创建临床工具、双头乳腺成像系统（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（Mayo）。我们的第二个目标是展示相机用作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型放射性药物中的潜在应用。在快速通道 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，具有采集、处理、肿瘤定量和同步双同位素功能。第一阶段将制造一台经过测试的原型相机，另外两台相机将模拟原始相机，并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腺成像系统（由 GM 开发）和图像数据定量分析软件（由 Mayo 开发）的临床实用性。这将通过多中心试点研究来完成。三个地点将进行一项患者研究，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，3) 证明其评估新的有前途的放射性药物的能力。次要目标将在第二阶段完成，并将在所有三个临床中心进行。