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）：使用俯卧活检台并通过成像引导的立体定向大芯针活检现已被接受作为开放手术活检的替代方案，用于乳房X光检查发现的不可触及的乳腺病变。与以前的微创技术（例如细针抽吸）相比，可以去除足够的组织以进行可靠的病理学检查。据报道，诊断的手术确认率为 95%，并且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后续针刺活检或手术活检。正常的诊断可能意味着乳房X光检查中看到的原始病变被遗漏。取样不足是针吸活检后乳腺组织诊断正常的主要原因。这种情况发生在 2% 到 10% 的手术中。针本身可能会模糊病变的图像，或者由于致密的乳房组织而难以看到病变，或者由于立体定向瞄准设备的压缩伪影，病变可能从其预期位置移动。在活检针的组织采集孔径处实时检测目标病变的方法可以减少采样不足的发生，并有可能加快整个过程。为此，提出了通过活检针部署的光纤拉曼光谱探头。拉曼光谱是病变检测的特别好的候选者，因为它对通常与此类病变相关的微钙化高度敏感。 X 射线乳房X 线摄影是在最早、最可治愈的阶段检测不可触及乳腺癌的标准程序。微钙化是钙盐的小而固体沉积物，通常与癌性病变相关，其强烈吸收 X 射线，因此在乳房 X 光检查上显示为高对比度阴影。他们的存在可能会导致转诊进行立体定向穿刺活检。在拉曼光谱中，这些微钙化通过组织散射的近红外光光谱中强烈、尖锐、易于区分的峰来表示。由于组织的化学成分，该光谱还包含更宽的峰。这些峰值幅度的更细微变化可以直接表明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离体临床研究中得到了证明。侧视拉曼针探针尚未在体内得到证实。在第一阶段，将设计、构建实用的拉曼针探针，并在来自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建立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，第二阶段仪器将被证明可以减少组织取样不足的发生，并充分提高取样效率，以减少这些程序所需的总时间，从而节省后续活检程序的成本和随之而来的患者痛苦。公共健康相关性：该计划将开发一种光纤拉曼光谱探头，该探头将部署在立体定向乳腺活检针内部，以实时指示组织采集孔径何时已正确定位在微钙化和/或可疑组织旁边。之前通过乳房X光检查发现。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”，“遗漏”的定义是未能检索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。