Molecular breast imaging to guide early-stage patient care

描述(申请人提供)：分子乳房成像指导早期患者护理分子乳房成像(MBI)有朝一日将为患者治疗提供决策指导，而不需要执行活检-也就是不需要切除通常被发现是正常的组织。MBI未来对女性健康的好处将消除数月的紧张观察和等待时间，并将指导化疗或手术决定走向最佳结果。在传统的乳房X光检查中，通过在胶片上投射阴影，经常可以看到可疑的生长。然而，在密集但正常的组织的背景下，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：微量的药物在异常组织中被摄取，然后将伽马射线照射到位于乳房附近的成像仪器。这些成像药物，也被称为“生物标记物”，可以被选择来探测医生直接关心的特定生物过程。例如，肿瘤的侵袭性或侵袭性可以通过专门针对细胞增殖(即细胞分裂和组织生长的速度)的生物标记物来探测。其他生物标记物可以“点亮”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。其中一个过程，即细胞增殖功能的代谢率，是由被称为99mTC-Sestamibi(简称MIBI)的显像剂探测的。上世纪90年代，通过使用一种名为“愤怒相机”的成像设备，这种药物被认为与乳腺癌有关。这种设备设计于1957年，可以灵活地对任何器官(从前列腺到大脑)以及全身进行成像。直到最近几年，愤怒相机才被专门设计用于对器官，即心脏进行成像。目前的提案描述了另一种特殊设计的相机--分子乳房成像仪，它使用一种新的双头固态探测器成像，这比已有52年历史的Anger方法有了明显的改进。这种探测器是由申请机构Gamma Medica-IDEAS(加利福尼亚州北岭GM-I)与梅奥诊所的研究人员合作开发的。梅奥诊所(Mayo Clinic)的奥康纳(O‘Connor)博士(该项目的研究人员之一)进行的临床试验表明，对于乳房致密的女性--即难以投射阴影的女性--的结果优于乳房X光检查。奥康纳博士还证明了MBI是非常具体的，也就是说，导致很少会导致令人担忧的但正常的活检的“假阳性”。目前的提案描述了由Gamma Medica-IDEAS运营的一个项目，涉及梅奥诊所、锡达斯-西奈医学中心和港湾-加州大学洛杉矶分校的临床研究合作。其目的是将双探头MBI扫描仪商业化，加强对明确界定的女性人群常规使用MIBI的理由，并将新的生物标记物与患者和疾病阶段联系起来，以便后续决策受到MBI结果的非侵入性指导。 公共卫生相关性：分子乳房成像指导早期患者护理非侵入性分子成像有望在降低成本和不确定性的同时有利于乳腺癌患者的护理。这将通过对选定的高危妇女人群进行筛查并提供明确的诊断和治疗指导来实现。我们提出了一种高精度仪器的商业化计划，该仪器能够在乳腺癌最早、最可治疗的阶段对分子显像剂进行成像，从而优化决策，以改善和降低成本效益。

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