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）：七分之一的女性一生中会患乳腺癌，这意味着一生中患这种疾病的概率为 13%。每年有近22万新发乳腺癌病例；其中 75% 的病例处于早期（I 期或 II 期）。在早期阶段，乳腺癌患者可以通过保乳手术 (BCS) 进行治疗。初次手术后，高达 40% 的病例会因手术切缘不足而导致局部复发，肿瘤切除部位残留有活癌细胞（即阳性切缘）。我们建议使用一种新颖的设备来降低 BCS 中因切缘不足而导致的 40% 复发率，该设备可以可靠且精确地对肿块切除术后腔进行消毒，在术中通过传导热消融创建无肿瘤腔。我们设计、制造并测试了一种能够在体内实现高效传导热消融的装置，如本提案的初步研究所示。基于这些结果，我们假设传导性间质热疗（CITT）可以可靠、精确地在靶组织中引起不可逆的热损伤，从而在原发性肿瘤切除后对手术边缘进行“消毒”。我们的最终目标是我们的设备将成为 BCS 的术中治疗方法，以减少因手术切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 在创造负切缘方面的控制力和可预测性以及 CITT 切缘消融的临床前疗效。为实现这一目标，我们将追求以下具体目标。具体目标 1. 展示我们在猪模型体内控制 CITT 造成的热损伤程度的能力。具体目标 2. 证明 CITT 可以在体内可靠地产生负裕度。我们的长期目标是通过将恶性肿瘤手术切除与 CITT 有效、可预测的边缘热消融相结合，开发乳腺癌当日诊断和一线治疗的新治疗模式；重要的是，这种方式对患者和手术团队都是安全的。通过进一步研究，它还可以应用于涉及实体瘤手术切除的其他类型的癌症（例如肺癌、肾癌、头颈癌）。