Robotic Haptic Feedback System for Bx/RFA of Breast Tumor under Continuous MRI

描述（由申请人提供）：美国癌症协会估计，仅在2008年，美国将有182460名妇女被诊断患有乳腺癌，40480名妇女将死于乳腺癌。如今每8个出生的女性中就有1个可能在其一生中被诊断出患有乳腺癌。尽管这些统计数字令人沮丧，但由于过去十年在诊断和治疗方面的创新，积极的趋势是明显的。最近，在《柳叶刀》和《新英格兰医学杂志》上发表的大规模研究表明，核磁共振成像是诊断乳腺癌的有效工具。因此，将诊断与基于MRI的活检（Bx）结合将更好地描绘肿瘤边缘。对于乳腺癌的治疗，射频消融（RFA）已成为一种有前途的早期乳腺癌治疗方法，具有最大的有效性和保护健康的乳房组织，而无需完全的手术干预。虽然超声（US）和计算机断层扫描（CT）是RFA的成像方式，但它们并非没有缺点。在美国，针头放置的精度受到限制，RFA过程中由于微泡形成的图像失真使肿瘤的可视化模糊不清。CT缺乏像MRI那样提供良好的软组织对比的能力，也使患者暴露在辐射剂量下。另一方面，MRI提供了出色的软组织对比，无电离辐射，在消融部位有准确的热成像图。尽管RFA在治疗多种类型病变方面的应用已经得到证实，但肿瘤的复发率并没有人们期望的那么低（8-47%）。RFA后的癌症复发或使用US、CT或MRI进行乳腺活检时的误诊可能是基于早期获得的图像而不是在连续的MRI指导下规划肿瘤轨迹的结果。虽然在针头放置后进行主观评估，但即使是轨迹上的小误差也可能导致活检和RFA的次优结果。因此，我们提出了一种新颖的机器人方法，该方法在连续MRI下具有触觉反馈，具有正面通道（从磁孔头部）和斜角度针驱动能力，可用于乳房活检和射频消融，从而最大限度地减少活检期间的采样误差，并在射频消融期间提供最佳治疗。所提出的系统将是当前MRI“引导”侧向（左侧或右侧）入路的重大改进，其针头轨迹角度有限。在最基本的层面上，该项目旨在为医生提供：1)在连续MRI下进行活检和准确递送RFA探针的能力；2)具有触觉反馈能力的远程操作机器人系统，帮助医生引导活检和RFA针具有正面进入和斜角度针驱动能力，使更大的进入角度能够到达乳房的各个区域。为了实现这一目标，我们从马里兰大学医学院和美国国立卫生研究院组建了一支由工程师和临床医生组成的优秀团队，参与这个极其重要的医疗保健项目。

DESCRIPTION (provided by applicant): The American Cancer Society estimates that 182,460 women will be diagnosed with breast cancer and that 40,480 women will die of breast cancer in the United States alone in 2008. One in 8 women born today is likely to be diagnosed with breast cancer during their lifetime. Although these statistics are discouraging, positive trends are evident as a result of innovations in diagnosis and treatment over the past decade. Recent, large scale studies reported in The Lancet and The New England of Journal of Medicine demonstrate the value of MRI as an effective tool in the diagnosis of breast cancer. Hence, coupling diagnosis with MRI based biopsy (Bx) will lead to better delineation of the tumor margin. For breast cancer treatment, radiofrequency ablation (RFA) has emerged as a promising approach for early stage breast cancer with maximum effectiveness and conservation of healthy breast tissue without full surgical intervention. While Ultrasound (US) and Computed tomography (CT) is the imaging modality for RFA, they are not without their drawbacks. In US, there is limitation on the precision with which a needle placement can be performed and the image distortion due to the formation of microbubbles during RFA obscures the visualization of the tumor. CT lacks the ability of providing soft tissue contrast as good as MRI and also exposes the patients to radiation dose. MRI on the other hand provides excellent soft-tissue contrast, no ionizing radiation, and accurate thermographic maps at the ablation site. Although the utility of RFA has been demonstrated in treating several types of lesion, the recurrence rate of tumors has not been as low as one would desire (8-47%). The recurrence of cancer after RFA or misdiagnosis in a breast biopsy using US, CT, or MRI could be a result of planning the trajectory towards the tumor based on images obtained earlier and not under continuous MRI guidance. Although a subjective evaluation is performed after the placement of the needle, even small errors in the trajectory could lead to sub- optimal results for biopsy and RFA. Hence, we propose a novel robotic approach with haptic feedback under continuous MRI with frontal access (from the head of the magnet bore) and oblique angle needle driving capability for both breast biopsy and RF ablation in a manner that minimizes sampling errors during biopsy and delivers optimal therapy during RF ablation. The proposed system will be a significant improvement of the current MRI 'guided' lateral (left or right side) approach with limited angle needle trajectory. At the very fundamental level, this project seeks to provide physicians with: 1) the ability to perform biopsy and accurate delivery of RFA probe under continuous MRI and 2) a teleoperated robotic system with haptic feedback capability to help the physician guide the biopsy and RFA needle with frontal access and oblique angle needle driving capability, enabling a wider access angle to various regions of the breast. To accomplish this, we have assembled an excellent team of engineers and clinicians from the University Of Maryland School Of Medicine and the NIH for this extremely important health-care project. PUBLIC HEALTH RELEVANCE: The American Cancer Society estimates that 182,460 women will be diagnosed with breast cancer and that 40,480 women will die of breast cancer in the United States alone in 2008. The purpose of this project is to develop a novel robotic system that will work under continuous magnetic resonance imaging for both breast biopsy (Bx) and radiofrequency ablation (RFA) of breast tumor.