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Raman spectroscopy probes for assisting stereotactic breast biopsy needle placeme

拉曼光谱探针辅助立体定向乳腺活检针放置

基本信息

批准号：
7746180
负责人：
STEPHEN FREDERICK FULGHUM
金额：
$ 9.98万
依托单位：
NEWTON LABORATORIES
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-08-01 至 2010-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7746180
关键词：
Algorithms Biopsy Biopsy Specimen Breast Breast Microcalcification Calcium Calcium Oxalate Caliber Cancerous Characteristics Chemicals Clinic Clinical Clinical Research Collaborations Core Biopsy Coupled Data Deposition Detection Development Diagnosis Diagnostic Distal Distress Durapatite Effectiveness Environment Exhibits Failure Fine needle aspiration biopsy Fingerprint Fluorescence Human Image Laboratories Lasers Lesion Malignant Neoplasms Mammary Gland Parenchyma Mammography Measurement Mechanics Methods Modeling Morphologic artifacts Needle biopsy procedure Needles Normal tissue morphology Operative Surgical Procedures Optics Palpable Pathology Pathology Report Patients Phase Positioning Attribute Procedures Raman Spectrum Analysis Real-Time Systems Reporting Roentgen Rays Running Salts Sampling Shadowing (Histology)Side Site Solid Specimen Spectrum Analysis Speed Staging Surface System Systems Analysis Techniques Testing Time Tissue Banking Tissue Banks Tissue Sample Tissues breast lesion cost design follow-up improved in vivo instrument light scattering malignant breast neoplasm millimeter minimally invasive pressure programs prototype public health relevance seal

项目摘要

DESCRIPTION (provided by applicant): Stereotactic, large-core, needle biopsy using a prone biopsy table and guided by imaging, is now accepted as an alternative to open surgical biopsy for non-palpable breast lesions discovered by mammography. Compared to previous minimally-invasive techniques, such as fine needle aspiration, sufficient tissue is removed to allow for reliable pathology. Surgical confirmation rates of 95% for diagnosis have been reported and the method is considered a safe alternative to surgical biopsy provided that follow- up needle biopsies or surgical biopsies are performed in the case of a subsequent normal breast tissue diagnosis. A normal diagnosis may mean that the original lesion seen on mammography was missed. Inadequate sampling is the primary reason for a normal breast tissue diagnosis following needle biopsies. This occurs in 2 to 10% of procedures. The needle itself may obscure the image of the lesion or the lesion may be difficult to see because of dense breast tissue or the lesion may move from its expected position due to compression artifacts of the stereotactic targeting apparatus. A means of detecting the target lesions, in real time, at the tissue acquisition aperture of the biopsy needle could reduce the occurrence of inadequate sampling and potentially speed up the overall procedure. A fiberoptic Raman spectroscopy probe, deployed through the biopsy needle, is proposed for this purpose. Raman spectroscopy is a particularly good candidate for lesion detection because it is highly sensitive to microcalcifications which are often associated with such lesions. X-ray mammography is the standard procedure for detecting non-palpable breast cancers at their earliest, most-curable stage. Microcalcifications are small, solid deposits of calcium salts, often associated with cancerous lesions, which strongly absorb x-rays and thus show up as high-contrast shadows on mammograms. Their presence may result in a referral for a stereotactic needle biopsy. In Raman spectroscopy these microcalcifications are indicated by strong, sharp, easily distinguished peaks in the optical spectrum of near-infrared light scattered from the tissue. This spectrum also contains broader peaks due to the chemical constituents of tissue. More subtle shifts in the amplitudes of these peaks can indicate the presence or absence of cancer directly. This diagnostic ability of Raman spectroscopy has already been demonstrated in small, ex-vivo, clinical studies. Side-looking Raman needle probes have yet to be demonstrated in-vivo. In Phase I a practical Raman needle probe will be designed, built and tested on ex-vivo breast tissue cores from large-core needle biopsies. In Phase II a full diagnostic system with real-time analysis capability will be built and tested, in-vivo, during stereotactic needle biopsy procedures. If successful, the Phase II instrument will be shown to reduce the occurrence of inadequate tissue sampling and improve the efficiency of sampling sufficiently to reduce the overall time required by these procedures, saving the cost of subsequent biopsy procedures and the attendant patient distress. PUBLIC HEALTH RELEVANCE: This program will develop a fiberoptic Raman spectroscopy probe which will be deployed inside of a stereotactic breast biopsy needle to indicate, in real time, when the tissue acquisition aperture has been correctly positioned next to microcalcifications and/or suspicious tissue which has been previously found through mammography. This system should reduce the number of biopsy samples necessary to retrieve known microcalcifications and minimize potential "misses", defined as a failure to retrieve microcalcifications coupled with a pathology report of normal tissue. The result should be a reduction of both procedure time and patient distress.

描述（由申请人提供）：使用俯卧活检床并在成像引导下进行立体定向、大芯针穿刺活检，目前已被接受为乳腺X线摄影发现的不可触及乳腺病变的开放手术活检的替代方法。与先前的微创技术（例如细针抽吸）相比，去除足够的组织以允许可靠的病理学。据报道，手术确诊率为95%，该方法被认为是手术活检的安全替代方法，前提是在随后诊断为正常乳腺组织的情况下进行随访针吸活检或手术活检。正常的诊断可能意味着在乳房X线摄影中看到的原始病变被错过了。不充分的采样是针吸活检后正常乳腺组织诊断的主要原因。这发生在2%到10%的手术中。针本身可能使病变的图像模糊，或者由于致密的乳房组织而可能难以看到病变，或者由于立体定向靶向设备的压缩伪影，病变可能从其预期位置移动。在活检针的组织采集孔处真实的时间检测目标病变的手段可以减少不充分采样的发生并且潜在地加速整个过程。为此，提出了通过活检针部署的光纤拉曼光谱探头。拉曼光谱是用于病变检测的特别好的候选者，因为它对通常与这种病变相关的微钙化高度敏感。X射线乳腺摄影是在最早、最容易治愈的阶段检测不可触及的乳腺癌的标准程序。微钙化是钙盐的小的固体沉积物，通常与癌性病变有关，其强烈吸收X射线，因此在乳房X线照片上显示为高对比度阴影。它们的存在可能导致转诊进行立体定向穿刺活检。在拉曼光谱中，这些微钙化由从组织散射的近红外光的光谱中的强的、尖锐的、容易区分的峰指示。由于组织的化学成分，该光谱还包含更宽的峰。这些峰的振幅的更微妙的变化可以直接指示癌症的存在或不存在。拉曼光谱的这种诊断能力已经在小型的离体临床研究中得到证实。侧视拉曼针探针尚未在体内得到证实。在第一阶段，将设计、制造实用的拉曼针探头，并在大芯针活检的离体乳腺组织芯上进行测试。在第二阶段，将在立体定向穿刺活检过程中构建并在体内测试具有实时分析能力的完整诊断系统。如果成功的话，第二阶段的仪器将被证明可以减少组织采样不足的发生，并充分提高采样效率，以减少这些程序所需的总时间，节省后续活检程序的成本和伴随的患者痛苦。公共卫生相关性：该项目将开发一种光纤拉曼光谱探头，该探头将部署在立体定位乳腺活检针内，以真实的时间指示组织采集孔径何时正确定位在微钙化和/或先前通过乳房X线摄影发现的可疑组织旁边。该系统应减少检索已知微钙化所需的活检样本数量，并最大限度地减少潜在的“遗漏”，即未能检索到微钙化以及正常组织的病理报告。结果应该是减少手术时间和患者痛苦。