Integrated three dimensional anatomic and molecular breast imaging

描述(申请人提供)：数字X-射线乳腺断层合成(XBT)正在由主要的乳腺成像设备制造商开发，并有望在未来几年内成为临床现实。虽然XBT通过减少叠加的纤维腺组织的遮盖效应，与2-D全场数字乳腺摄影相比，可能会提高小肿块的显着性，但它仍然是一种解剖成像方式，因此，为了提高特异性和阳性预测值，需要能够提供补充信息的功能成像方式。使用紧凑型伽马相机的分子乳房成像(MBI)允许以高分辨率对整个乳房进行功能成像，并已显示出作为FFDM的补充方式的前景。为了获得能够与XBT三维结构图像数据准确关联的功能图像数据，我们团队开发了一种独特的双模式断层扫描(DMT)乳房扫描仪，该扫描仪在一个集成的机架上结合了X射线乳房断层合成和分子乳房成像断层合成(MBIT)，从而实现了三维解剖图像数据和功能图像数据之间的精确定位共配准。我们的测量表明，与2-D MBI相比，Mbit的使用大大提高了病变的对比度和图像的信噪比，特别是对于小的、深层次的病变。DMT扫描仪最近在一项试点临床研究中进行了测试，并被证明在特异性、阳性预测值和准确性方面优于单独使用XBT。这些初步结果促使了这项资金申请，以评估扫描仪在更大规模的女性队列中的临床表现。在拟议的人体研究之前，X射线和分子成像组件将进行升级，以获得更高的检测效率(XBT和Mbit)、更短的采集时间(XBIT)、更低的噪声(XBT)和更好的患者定位(XBT和Mbit)。DMT乳腺成像的潜在临床作用包括：为乳房X光检查/超声检查可疑的妇女解决问题，特别是那些具有放射敏感性的乳房；筛查高危妇女，以帮助在乳房X光检查阳性后选择活组织检查目标，特别是在有多个可疑区域的患者；检查在乳房X光检查或超声检查中未显示的可触及的肿块；对有乳腺癌个人病史的患者进行癌症监测；为已知癌症的妇女进行手术前规划，以确定疾病程度(多焦点对侧乳房)；对于因NSF/NFD、肥胖、幽闭恐惧症而无法进行MRI的女性，或安装了心脏起搏器或其他含有铁磁性成分的植入物的女性，可作为乳房MRI的替代品；以及用于监测对新辅助治疗的反应。

DESCRIPTION (provided by applicant): Digital x-ray breast tomosynthesis (XBT) is under development by major manufacturers of breast imaging equipment and is expected to become a clinical reality within the next few years. Although XBT is likely to improve the conspicuity of small masses compared to 2-D full field digital mammography (FFDM) by reducing the masking effect of superimposed fibroglandular breast tissue, it remains an anatomic imaging modality and therefore functional imaging modalities that can provide complementary information are desirable in order to improve specificity and positive predictive value. Molecular breast imaging (MBI) using compact gamma cameras permits functional imaging of the entire breast at high resolution and has shown promise as a complementary modality to FFDM. With the goal of obtaining functional image data that can be accurately correlated with the 3-D structural image data of XBT, our group has developed a unique dual modality tomographic (DMT) breast scanner that combines x-ray breast tomosynthesis and molecular breast imaging tomosynthesis (MBIT) on a single integrated gantry, thereby permitting accurate localization co- registration between 3-dimensional anatomic and functional image data. Our measurements have shown that compared to 2-D MBI, the use of MBIT greatly improves lesion contrast and image signal- to-noise ratio, especially for small, deep-seated lesions. The DMT scanner has been recently tested in a pilot clinical study and proved superior to XBT alone in specificity, positive predictive value, and accuracy. These preliminary results have motivated this application for funding to evaluate the scanner's clinical performance among a larger cohort of women. Prior to the proposed human study both the x-ray and molecular imaging components will be upgraded for greater detection efficiency (XBT and MBIT), shorter acquisition time (XBIT), lower noise (XBT), and improved patient positioning (XBT and MBIT). Potential clinical roles for DMT breast imaging include problem solving for women with equivocal mammographic/ultrasound studies, especially those with radiodense breasts; screening high-risk women, as an aid in biopsy target selection following a positive mammogram, particularly in patients with multiple suspicious areas; workup of palpable masses not demonstrated on mammography or ultrasound; cancer surveillance in patients with a personal history of breast cancer; pre-surgical planning for women with known cancer for determination of disease extent (multi-focal, contralateral breast); as an alternative to breast MRI for women for whom MRI is impossible because of NSF/NFD, obesity, claustrophobia, or who have cardiac pacemakers or other types of implants containing ferromagnetic components; and for monitoring response to neoadjuvant therapy.