Breast Tissue ablation by Conductive Heating

传导加热乳腺组织消融

• 批准号: 7148390
• 负责人: GAL SHAFIRSTEIN
• 金额: $ 16.74万
• 依托单位: UNIV OF ARKANSAS FOR MED SCIS
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-07-01 至 2008-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7148390
• 关键词: breast neoplasms; heat; mammary gland; model; neoplasm /cancer; tissues

DESCRIPTION (provided by applicant): Breast cancer affects 1 in 7 women during their lifetime, which translates to a 13% lifetime probability of developing the disease. Nearly 220,000 new cases are diagnosed with breast cancer each year; in 75% of these cases, the disease is at early stage (I or II). At these early stages, breast cancer patients can be treated via breast conservation surgery (BCS). Following the initial surgery, up to 40% of the cases result in local recurrence due to inadequate surgical margins with viable cancer cells left at the lumpectomy site (i.e. positive margins). We propose to reduce the 40% recurrence rates caused by inadequate margins in BCS using a novel device that reliably and precisely sterilizes the post-lumpectomy cavity, creating a tumor-free cavity, intraoperatively, via conductive thermal ablation. We have designed, built, and tested a device that enables highly effective conductive thermal ablation in vivo, as shown in the Preliminary Studies of this proposal. Based on these results, we hypothesize that conductive interstitial thermal therapy (CITT) can reliably and precisely induce irreversible thermal damage in targeted tissue to "sterilize" surgical margins after primary tumor resection. Our ultimate goal is that our device will become an intraoperative treatment in BCS to reduce local tumor recurrence resulting from inadequate surgical margins. In this project, our objective is to demonstrate the control and predictability of CITT in creating negative margins and the preclinical efficacy of margin ablation by CITT. To achieve this objective, we will pursue the following specific aims. Specific Aim 1. Demonstrate our ability to control the extent of thermal damage resulting from CITT, in vivo, in a swine model. Specific Aim 2. Demonstrate that CITT can reliably create negative margins, in vivo. Our long-term goal is to develop a new treatment paradigm for same-day diagnosis and first-line treatment of breast cancer by combining surgical resection of malignant tumors with effective, predictable thermal ablation of the margins by CITT; importantly, this modality is safe for both the patient and the surgical team. It can also be applied, through further research, to other types of cancers (e.g. lung, kidney, head and neck) that involve surgical resection of solid tumors.

描述（由申请人提供）：乳腺癌在一生中影响7分之一的女性，这转化为患上这种疾病的终生概率13％。每年将近22万例新病例被诊断出患有乳腺癌；在这些病例中，有75％是在早期（I或II）。在这些早期阶段，乳腺癌患者可以通过乳房保存手术（BCS）进行治疗。初次手术后，高达40％的病例导致局部复发，这是由于手术边缘不足而导致肿瘤切除术部位剩下的可行癌细胞（即阳性边缘）。我们建议使用一种新型设备可靠地对倾斜后切除术腔，在内部术中通过导电热消融，降低BCS中边缘不足引起的40％复发率。我们已经设计，构建和测试了一种可以在体内实现高效的导电热消融的设备，如该提案的初步研究所示。基于这些结果，我们假设导电间质热疗法（CITT）可以可靠，精确地诱导靶向组织中不可逆的热损伤，以在原发性肿瘤切除后“消毒”手术缘。我们的最终目标是，我们的设备将成为BCS的术中治疗，以减少由于手术边缘不足而导致的局部肿瘤复发。在这个项目中，我们的目标是证明CITT在产生负边缘的控制和可预测性，以及CITT通过边缘消融的临床前疗效。为了实现这一目标，我们将追求以下特定目标。具体目标1。证明我们能够控制猪模型中CITT，体内CITT引起的热损伤程度的能力。具体目标2。证明CITT可以可靠地产生负缘，体内。我们的长期目标是通过将恶性肿瘤的外科手术切除与CITT对边缘的有效，可预测的热消融相结合，以开发一种新的治疗范式，用于当天诊断和对乳腺癌的一线治疗；重要的是，这种方式对患者和外科团队都是安全的。也可以通过进一步研究将其应用于涉及实体瘤外科切除术的其他类型的癌症（例如肺，肾脏，头颈）。