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年总共诊断出240,430例新的乳腺癌(178,400例新的浸润性乳腺癌和62,030例原位乳腺癌)。这些患者中约有18万人接受了保乳手术(BCS)，也称为乳房切除术。最近的多项研究表明，在18万名患者中，有惊人的20%-70%(平均45%或~81000名女性)由于在第一次BCS时癌症切除不彻底而不得不再次接受手术。这项研究的长期目标是向市场推出一种临床上有用的、术中评估乳腺肿瘤边缘的设备。本研究的目的是开发一种可用于临床试验的器械，并评估其作为术中常规使用工具的实用价值。拟议工作的具体目标是：(1)设计、制造和鉴定一种多通道光学光谱成像系统，该系统将提供从乳房组织内深达2毫米的二维测量，以便在新切除的肿块切除标本中检测接近和阳性的肿瘤边缘，(2)对关于组织模体的设备设计规范进行验证性研究，以及(3)在实际临床环境中对该设备进行关键评估。这项拟议的技术将是一种多通道光学分析设备，用于术中对从接受保乳手术(部分乳房切除)的患者切除的标本的边缘进行成像。理论上，这种光学分析系统将帮助指导外科医生要么在切缘为负的情况下完成手术，要么在切缘为正的情况下重新切除额外的组织。这项拟议的临床研究将成为未来与乳腺癌患者手术中有效评估肿瘤边缘相关的技术发展的重要数据库。成功完成这项研究的长期目标将为乳腺癌患者(每年避免数万例不必要的手术)以及外科医生、医院和卫生保健提供者带来重大好处。这项研究中提出的技术也可能被用于评估其他类型癌症患者的肿瘤边缘，扩大这项研究的潜在健康影响。公共卫生相关性：这项STTR提案的目标是开发一种非侵入性的多通道光学分析设备，用于术中对从接受保乳癌症手术的患者切除的组织标本中的肿瘤边缘进行成像。这项拟议的研究与公众健康密切相关，因为这项研究可能有助于减少每年数万次不必要的乳房再次切除手术，并相应地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癌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.