Molecular breast imaging to guide early-stage patient care

分子乳腺成像指导早期患者护理

• 批准号: 7785354
• 负责人: Douglas J. Wagenaar
• 金额: $ 100万
• 依托单位: GAMMA MEDICA-IDEAS, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-24 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7785354
• 关键词: Anger; Awareness; Benefits and Risks; Biological Markers; Biological Process; Biopsy; Brain; Breast; Cancer Patient; Cell Proliferation; Cell division; Cell physiology; Clinic; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Collaborations; Collimator; Computer software; Conduct Clinical Trials; DCNU; Data; Decision Making; Development; Devices; Diagnosis; Disease; Documentation; Dose; Economics; Engineering; Ensure; Feedback; Film; Fluorescence; Funding; Future; Gamma Rays; Goals; Growth; Head; Heart; Hormone Receptor; Hot Spot; Image; Institution; Isotopes; Lead; Lesion; Light; Literature; Mammography; Marketing; Measurement; Mechanics; Medical center; Metabolic; Methods; Molecular; Molecular Analysis; Multi-Institutional Clinical Trial; Normal tissue morphology; Operative Surgical Procedures; Organ; Outcome; Outcomes Research; Patient Care; Patients; Performance; Pharmaceutical Preparations; Phase; Physicians; Population; Populations at Risk; Process; Prostate; Radiation; Recovery; Reporting; Research; Research Design; Research Personnel; Resolution; Risk; Running; Scanning; Schedule; Screening procedure; Shadowing (Histology); Small Business Innovation Research Grant; Specific qualifier value; Spottings; Staging; Standardization; System; Task Performances; Technetium Tc 99m Sestamibi; Technology; Thallium; Thick; Time; Tissues; Translating; Uncertainty; Vitamin B 12; Woman; Women' s Health; base; cancer type; chemotherapy; commercialization; cost; design; detector; dissemination trial; flexibility; high risk; imaging probe; improved; innovation; instrument; malignant breast neoplasm; molecular imaging; product development; programs; prototype; public health relevance; research clinical testing; solid state; success; tumor

DESCRIPTION (provided by applicant): Molecular Breast Imaging to Guide Early-Stage Patient Care Molecular Breast Imaging (MBI) will one day provide decision guidance for patient management without the need to perform a biopsy - that is without the need to cut out tissue that often is found to be normal. MBI's future benefit to women's health will obviate stressful watching and waiting periods of months, and will guide chemotherapy or surgery decisions toward optimized outcomes. A suspicious growth is often seen in conventional mammography by casting its shadow on film. However, often the shadow becomes inconspicuous in the background of dense but normal tissues. MBI forms images through a completely different process: drugs of trace amounts are taken up in the abnormal tissues, and then shine gamma-rays out to an imaging instrument located near the breast. These imaging drugs, also known as "biomarkers", can be selected to probe specific biological processes of immediate concern to the physician. For example, the aggressiveness or invasiveness of a tumor can be probed by a biomarker designed to specifically target cellular proliferation (i.e., the rate of cell division and tissue growth). Other biomarkers can "light up" tumors featuring specified hormone receptors or other identifying cellular features known to be associated with certain types of cancer. One of these processes, namely the metabolic rate of proliferative cellular functions, is probed by the imaging agent known as 99mTc-sestamibi ("MIBI" for short). This agent was associated with breast cancer in the 1990s through the use of an imaging instrument known as the "Anger camera". This device, which was designed in 1957, has flexible utility in imaging any organ (from prostate to brain) as well as whole bodies. Only in recent years has the Anger camera been specially designed for imaging of an organ, namely the heart. The current proposal describes another specially designed camera, the Molecular Breast Imager, which forms images using a new, dual-head solid state detector that is a distinct improvement over the 52-year old Anger method. This detector has been developed by the applicant institution, Gamma Medica- Ideas (GM-I, Northridge, CA) in collaboration with researchers at the Mayo Clinic. Clinical trials conducted by Dr. O'Connor of the Mayo Clinic (one of the investigators on this project) demonstrate results that are superior to mammography for women with dense breasts - i.e., those women in whom shadows are difficult to cast. Dr. O'Connor also has shown MBI to be very specific, that is, resulting in few "false positives" that would lead to worrisome yet normal biopsy. The current proposal describes a program run by Gamma Medica-Ideas and involving clinical research collaborations at the Mayo Clinic, Cedars-Sinai Medical Center, and Harbor-UCLA. The aims are to commercialize the dual-head MBI scanner, to strengthen the case for routine use of MIBI for well-defined populations of women, and to associate new biomarkers with patients and disease stage such that subsequent decisions are non-invasively guided by MBI results. PUBLIC HEALTH RELEVANCE: Molecular Breast Imaging to Guide Early-Stage Patient Care Non-invasive molecular imaging promises to benefit breast cancer patient care while reducing costs and uncertainties. This will be achieved by the screening of selected, at-risk populations of women and providing definitive diagnosis and therapy guidance. We propose a commercialization program for a highly accurate instrument capable of imaging molecular imaging agents at the earliest, most treatable stage of breast cancer, thereby optimizing decision making toward improved and cost-effective outcomes

描述（由申请人提供）：分子乳腺成像指导早期患者护理分子乳腺成像（MBI）有一天将为患者管理提供决策指导，而无需进行活检-即无需切除通常被发现正常的组织。MBI对女性健康的未来益处将消除数月的紧张观察和等待期，并将指导化疗或手术决策以优化结果。在传统的乳房X线摄影中，通过在胶片上投射阴影，经常可以看到可疑的生长物。然而，在致密但正常的组织背景中，阴影往往变得不明显。MBI通过一个完全不同的过程形成图像：微量药物被吸收在异常组织中，然后将伽马射线照射到位于乳房附近的成像仪器上。这些成像药物，也被称为“生物标志物”，可以被选择来探测医生直接关注的特定生物过程。例如，肿瘤的侵袭性或侵袭性可以通过被设计为特异性靶向细胞增殖的生物标志物来探测（即，细胞分裂和组织生长的速率）。其他生物标志物可以“照亮”具有特定激素受体或其他已知与某些类型癌症相关的识别细胞特征的肿瘤。这些过程之一，即增殖细胞功能的代谢率，通过被称为99 mTc-Sestamibi（简称“MIBI”）的成像剂探测。在20世纪90年代，通过使用被称为“愤怒相机”的成像仪器，这种药剂与乳腺癌有关。该设备于1957年设计，可灵活用于成像任何器官（从前列腺到大脑）以及整个身体。直到最近几年，Anger相机才被专门设计用于器官成像，即心脏。目前的提案描述了另一种专门设计的相机，分子乳腺成像仪，它使用一种新的双头固态探测器形成图像，这是对52年前的愤怒方法的明显改进。该检测器由申请机构Gamma Medica- Ideas（GM-I，Northridge，CA）与马约诊所的研究人员合作开发。马约诊所的奥康纳博士（该项目的研究者之一）进行的临床试验证明，对于乳腺致密的女性，结果上级于乳房X光检查-即，这些女人的影子很难投射。奥康纳博士还表明MBI是非常具体的，也就是说，导致很少的“假阳性”，这将导致令人担忧的，但正常的活检。目前的提案描述了一个由Gamma Medica-Ideas运行的项目，涉及马约诊所、Cedars-Sinai医疗中心和Harbor-UCLA的临床研究合作。其目的是将双头MBI扫描仪商业化，加强MIBI在明确定义的女性人群中的常规使用，并将新的生物标志物与患者和疾病阶段相关联，以便随后的决策由MBI结果非侵入性指导。 公共卫生相关性：分子乳腺成像指导早期患者护理非侵入性分子成像有望使乳腺癌患者护理受益，同时降低成本和不确定性。这将通过筛选选定的高危妇女群体并提供明确的诊断和治疗指导来实现。我们提出了一个商业化计划，用于一种能够在乳腺癌最早、最可治疗的阶段对分子成像剂进行成像的高精度仪器，从而优化决策，以改善和节省成本