Fast Spectral Imaging Device For Tumor Margin Mapping

描述（由申请人提供）：美国癌症协会估计，2007年共诊断出240，430例新发乳腺癌（178，400例新发浸润性乳腺癌和62，030例新发原位乳腺癌）。这些患者中约有180，000人接受乳房保留手术（BCS），也称为乳房肿瘤切除术。最近的多项研究表明，在180，000名患者中，有20-70%的患者（45%或平均约81，000名女性）由于在第一次BCS时癌症切除不完全而不得不返回进行重复手术。本研究的长期目标是将用于乳腺肿瘤边缘评估的临床有用的术中器械引入市场。拟议研究的目的是开发一种临床试验就绪的设备，并评估其作为常规使用的术中工具的实际效用。拟议工作的具体目标是：（1）设计、制造和表征多通道光谱成像系统，该系统将提供从乳房组织内高达2 mm的深度的二维测量，以便检测新切除的乳房肿瘤切除术样本中的紧密和阳性肿瘤边缘，（2）对组织体模上的器械设计规范进行验证研究，以及（3）在实际临床环境中对器械进行关键评价。所提出的技术将是一种多通道光学分析设备，用于对从接受保乳手术（部分乳房切除术）的患者中切除的标本中的边缘进行术中成像。理论上，该光学测定系统将帮助引导外科医生在边缘为阴性时完成手术，或者在边缘为阳性时再次切除额外的组织。拟议的临床研究将作为一个重要的数据库，为未来的技术发展有关的有效术中评估肿瘤边缘的乳腺癌患者。成功完成这项研究的长期目标将为乳腺癌患者（每年防止成千上万的不必要手术）以及外科医生，医院和医疗保健提供者带来重大利益。这项研究中提出的技术也有可能用于评估其他类型癌症患者的肿瘤边缘，扩大研究的潜在健康影响。公共卫生相关性：该STTR提案的目标是开发一种非侵入性多通道光学测定装置，用于从接受保乳癌症手术的患者中切除的组织标本中的肿瘤边缘的术中成像。这项拟议的研究与公共卫生密切相关，因为它可能有助于每年减少数万例不必要的乳房再切除手术，并相应降低在第一次手术中完全切除癌症的侵袭性和非侵袭性乳腺恶性肿瘤患者的局部复发风险。

DESCRIPTION (provided by applicant): The American Cancer Society estimates that a total of 240,430 new breast cancers were diagnosed in 2007 (178,400 new cases of invasive breast cancer, and 62,030 new cases of in situ breast cancer). Approximately 180,000 of these patients undergo breast conserving surgery (BCS), also called lumpectomy. Multiple recent studies show that a staggering 20-70% of the 180,000 patients (45% or ~81,000 women on average) have to return for a repeat surgery due to incomplete removal of the cancer at the first BCS. The long-term objective of this research is the market introduction of a clinically useful, intra-operative device for breast tumor margin assessment. The objective of the proposed research is to develop a clinical-trial-ready device and to evaluate its practical utility as a routinely used intra-operative tool. The specific aims of the proposed work are: (1) to design, fabricate and characterize a multi-channel optical spectral imaging system that will provide two- dimensional measurements from a depth of up to 2 mm within breast tissues in order to detect close and positive tumor margins in freshly excised lumpectomy specimens, (2) to perform a verification study of the device design specifications on tissue phantoms and (3) to perform a critical evaluation of the device in a practical clinical setting. The proposed technology will be a multi-channel optical assay device for intraoperative imaging of margins in specimens excised from patients undergoing breast conserving surgery (partial mastectomy). It is theorized that this optical assay system will help guide the surgeon to either complete the surgery, when margins are negative, or re-excise additional tissue, when margins are positive. The proposed clinical study will serve as an important database for future technological developments related to effective intra-operative assessment of tumor margins in patients with breast cancer. Successful completion of the long-term objectives of this research will result in significant benefits to breast cancer patients (preventing tens of thousands of unnecessary surgeries each year) as well as surgeons, hospitals, and health-care providers. The technology proposed in this research could also potentially be utilized in the assessment of tumor margins in patients with other types of cancers, widening the potential health impact of the research. PUBLIC HEALTH RELEVANCE: The goal of this STTR proposal is to develop a non-invasive multi-channel optical assay device for intra-operative imaging of tumor margins in tissue specimens excised from patients undergoing breast conserving cancer surgery. The proposed research is significantly relevant to public health due to the potential to contribute to the reduction of tens of thousands of unnecessary breast re-excision surgeries each year, and the corresponding lowered risk of local recurrence in patients with invasive and non-invasive breast malignancies who have their cancer fully removed in the first surgery.