Real-time volumetric specimen imager for 3D intra-operative lumpectomy margin assessment

用于 3D 术中肿瘤切除术边缘评估的实时体积标本成像仪

基本信息

批准号：
9143325
负责人：
Xiao Han
金额：
$ 22.5万
依托单位：
CLARIX IMAGING CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-09-01 至 2018-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9143325
关键词：
Algorithmic Software Algorithms American College of Radiology Breast Breast Microcalcification Businesses Cancerous Capital Chicago Clinical Clinical Data Community Hospitals Cosmetics Data Devices Diagnostic radiologic examination Educational process of instructing Evaluation Excision Fiber Goals Growth Health Care Costs Human Image Image Analysis Imagery Lead Legal patent Location Marketing Mastectomy Morphology Nylons Operating Rooms Operative Surgical Procedures Outcome Outpatients Pathology Patient-Focused Outcomes Patients Performance Phase Physicians Production Ramp Repeat Surgery Research Resolution Risk Roentgen Rays Sales Scanning Sensitivity and Specificity Small Business Innovation Research Grant Specimen Structure Surgeon System Talents Technology Testing Three-Dimensional Image Three-Dimensional Imaging Time Tissues Universities Variant Work base breast lumpectomy breast surgery commercial application cost improved improved outcome meetings microCT next generation novel novel strategies programs prototype public health relevance standard of care tool tumor wound

项目摘要

DESCRIPTION (provided by applicant): We propose to develop a novel volumetric specimen imager (VSI) device for significantly reducing breast lumpectomy's reoperation rate and improving outcomes. Among the annual performance of >200,000 lumpectomies in the US, up to 40%[1,2] of patients need a reoperation, when post-surgery pathology examination reveals "positive margin", indicating incomplete tumor removal. Currently physicians rely on 2D specimen imaging for assessing margin status during surgery, which cannot adequately represent the 3D margin morphology[3]. We propose a next-generation VSI device that yields fully-3D images of the specimen with isotropic resolution, which can significantly improve margin assessment and provide precise guidance for immediate re-excision before closing wound. While conventional 3D imagers requires a long scan time (15- 30min.)[4] that disrupts surgical workflow, our VSI approach is enabled by a patented algorithm[6] that allows much faster imaging by substantially cutting down the amount of data to be collected[7], which offers high resolution 3D image within 2-3 minutes. In 4-5 years we plan to introduce VSI as the new standard of care for intra-operative lumpectomy margin assessment, which may reduce the re-excision rate to ~5% without unnecessary re-excision and mastectomy, thereby dramatically reducing healthcare costs and patient inconvenience while improving cosmetic outcomes. Our hypothesis for Phase I research is that the VSI can scan typical lumpectomy specimens within 3 minutes, yielding 3D images with over 90% margin-assessment sensitivity and specificity. The Specific Aims are: (1) to verify that image-quality requirements can be met by a calibrated VSI prototype, (2) to verify that scan-time requirements can be met by optimizing VSI parameters, and (3) To verify that VSI has higher sensitivity and specificity than SR for assessing lumpectomy margins. Reaching the above Aims will firmly establish the feasibility of VSI as a next-generation tool for 3D intra- operative margin assessment, and would reduce the technical risk of Phase II work, which include (1) fully optimization of VSI performance, (2) complete integration of the VSI to surgical workflow, and (3) larger-scale evaluation of VSI's clinical benefit with 200 lumpectomy specimens. In the US, about 6,000 surgical labs performing lumpectomy create an installed base estimated at $1B, among which large teaching programs and affiliated community hospitals are our lead customers, providing an early customer base of ~$7.5M.

描述（由申请人提供）：我们建议开发一种新型体积标本成像仪 (VSI) 设备，用于显着降低乳房肿瘤切除术的再次手术率并改善结果，在美国每年超过 200,000 例乳房肿瘤切除术中，高达 40%[1， 2]当术后病理检查显示“阳性切缘”时，患者需要再次手术，这表明肿瘤切除不完全，目前医生依靠二维标本成像来评估切缘状态。手术，它不能充分代表 3D 边缘形态 [3]，我们提出了一种下一代 VSI 设备，可以产生具有各向同性分辨率的标本的全 3D 图像，这可以显着改善边缘评估并为立即重新切除提供精确指导。虽然传统 3D 成像仪需要较长的扫描时间（15-30 分钟）[4]，这会扰乱手术工作流程，但我们的 VSI 方法是通过专利算法实现的[6]，该算法通过大幅减少扫描量来实现更快的成像。需要收集的数据[7]，可在 2-3 分钟内提供高分辨率 3D 图像，我们计划在 4-5 年内引入 VSI 作为术中肿瘤切除边缘评估的新护理标准，这可能会减少风险。 - 切除率达到约 5%，无需进行不必要的再次切除和乳房切除术，从而显着降低医疗成本和患者不便，同时改善美容效果。我们对 I 期研究的假设是，VSI 可以在 3 分钟内扫描典型的肿瘤切除标本，产生 3D。边缘评估灵敏度和特异性超过 90% 的图像具体目标是：(1) 验证校准的 VSI 原型是否可以满足图像质量要求，(2) 验证是否可以满足扫描时间要求。优化 VSI 参数，以及 (3) 验证 VSI 在评估肿瘤切除切缘方面比 SR 具有更高的敏感性和特异性。实现上述目标将坚定地确立 VSI 作为下一代工具的可行性。 3D术中切缘评估，并将降低II期工作的技术风险，其中包括（1）VSI性能的全面优化，（2）VSI与手术流程的完全集成，以及（3）更大规模的评估VSI 受益于 200 个肿瘤切除标本在美国，大约 6,000 个进行临床肿瘤切除术的手术实验室创建了估计价值 10 亿美元的安装基础，其中大型教学项目和附属社区医院是我们的主要客户，提供了早期客户群。约 750 万美元。