Integrated three dimensional anatomic and molecular breast imaging

描述（由申请人提供）：数字x射线乳房断层合成（XBT）是主要乳房成像设备制造商正在开发的，预计在未来几年内成为临床现实。虽然与二维全视野数字乳房x线摄影（FFDM）相比，XBT可能通过减少叠加纤维腺乳腺组织的掩蔽效应来提高小肿块的显著性，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价值，可以提供补充信息的功能成像方式是可取的。分子乳房成像（MBI）使用紧凑型伽玛相机，可以在高分辨率下对整个乳房进行功能成像，并有望成为FFDM的补充方式。为了获得与XBT三维结构图像数据准确相关的功能图像数据，我们团队开发了一种独特的双模态断层扫描（DMT）乳房扫描仪，该扫描仪将x射线乳房断层合成和分子乳房成像断层合成（MBIT）结合在一个集成龙门上，从而实现三维解剖和功能图像数据之间的精确定位共配准。我们的测量结果表明，与二维MBI相比，mbbi的使用大大提高了病灶对比度和图像信噪比，特别是对于小的深部病灶。DMT扫描仪最近在一项试点临床研究中进行了测试，并证明在特异性、阳性预测值和准确性方面优于单独使用XBT。这些初步结果促使这项申请获得资金，以评估扫描仪在更大的女性群体中的临床表现。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，以提高检测效率（XBT和MBIT），缩短采集时间（XBIT），降低噪声（XBT），并改善患者定位（XBT和MBIT）。DMT乳房成像的潜在临床作用包括解决乳房x光/超声检查不明确的妇女的问题，特别是那些有放射致密乳房的妇女；筛查高危妇女，作为乳房x光检查阳性后活检目标选择的辅助，特别是在有多个可疑区域的患者中；乳房x光检查或超声检查未发现的可触及肿块；有乳腺癌个人病史患者的癌症监测对已知患有癌症的妇女进行术前规划，以确定疾病程度（多灶性、对侧乳房）；对于因NSF/NFD、肥胖、幽闭恐惧症或心脏起搏器或其他类型含有铁磁成分的植入物而无法进行MRI检查的女性，作为乳房MRI的替代方案；并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. PUBLIC HEALTH RELEVANCE: The relevance of this research to women's health is that the breast scanner to be developed and tested constitutes a new type of device that can potentially improve the early detection and characterization of small cancers. The scanner acquires 3-dimensional digital mammography (structural) and 3-dimensional molecular imaging (functional) images in quick succession with the breast under mild, pain-free compression. It may be of particular value for women with dense breasts for whom normal mammography is less effective, for women with higher than average risk for developing breast cancer, and as a less costly, more accurate alternative to breast MRI.