Multi-modality detection of RCC Recurrence Post Ablation

消融后肾细胞癌复发的多模态检测

• 批准号: 10587731
• 负责人: John Eisenbrey
• 金额: $ 69.11万
• 依托单位: THOMAS JEFFERSON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-12-01 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10587731
• 关键词: 3-Dimensional; Ablation; Address; Adoption; Adverse event; Agreement; American; Blinded; Blood Vessels; Cancer Detection; Cicatrix; Clinical; Clinical Research; Contrast Media; Contrast Sensitivity; Data; Data Set; Deposition; Detection; Development; Diagnosis; Early identification; Encapsulated; Fat necrosis; Follow-Up Studies; Gases; Granulation Tissue; Hepatic; Image; Image Analysis; Imaging Techniques; Incidence; Inflammation; Inflammatory; Institution; Kidney; Lipids; Longterm Follow-up; Magnetic Resonance Imaging; Magnetism; Malignant Neoplasms; Microbubbles; Modality; Monitor; Multimodal Imaging; Operative Surgical Procedures; Pathology; Patient Recruitments; Patients; Performance; Pilot Projects; Predictive Value; Proteins; Protocols documentation; Reader; Recommendation; Recurrence; Recurrent Malignant Neoplasm; Recurrent disease; Reference Standards; Relapse; Renal Cell Carcinoma; Renal carcinoma; Renal function; Residual state; Resolution; Retreatment; Safety; Sample Size; Site; Specificity; Techniques; Testing; Time; Tissues; Ultrasonography; anatomic imaging; calcification; cancer recurrence; clinical application; clinically actionable; contrast enhanced; contrast enhanced computed tomography; cost; design; dosage; experience; follow-up; imaging approach; imaging detection; imaging modality; improved; kidney cortex; multimodality; portability; preservation; quantitative imaging; radiologist; real-time images; screening; sensor; standard of care; surveillance imaging; temporal measurement; tumor; ultrasound

Project Summary: Renal cell carcinoma (RCC) accounts for 3-5% of all cancers. Localized ablation is a recommended treatment for T1a renal cancers (approximately 25% of all RCC) and particularly important for the treatment of patients who are poor surgical candidates due to diminished renal function or with a solitary kidney. Post-ablation imaging protocols for detection of recurrence vary, but mainly rely on contrast-enhanced computed tomography (CECT) or contrast-enhanced magnetic resonance imaging (CEMRI) at 3-12 months intervals. However, detection of relapse based on detection of contrast enhancement within the ablation cavity can be challenging on both modalities – due to most imaging findings of recurrence being nonspecific because of changes in tumor size, enhancement from fat necrosis and scarring, and the development of calcifications following therapy. Additionally, these techniques can be problematic due to modality and contrast agent contraindications. As an alternative to CECT and CEMRI, contrast-enhanced ultrasound (CEUS) has gained acceptance for a variety of clinical applications. In small pilot studies, our group has demonstrated the ability of CEUS to monitor for both residual and recurrent RCC following percutaneous ablation with 100% sensitivity and no adverse events. While encouraging, our findings were based on a relatively small sample size and, with an overall specificity of the technique that ranged from 75-96%, primarily due to an inability to properly identify the boundaries of the ablation cavity from the surrounding renal cortex. To assess the clinical promise of CEUS, we propose a larger, fully powered study, recruiting patients across multiple institutions and using multi-modality imaging techniques to overcome these limitations and enable clinical adoption. In our first specific aim, we will characterize the sensitivity, specificity, positive and negative predictive value, and inter-reader agreement of both 2D CEUS and contrast-enhanced cross-sectional imaging for detecting recurrent RCC following ablation; we will use a combination of long-term follow-up imaging and tissue pathology as a reference standard, instead of relying on CECT or CEMRI. At each site, blinded radiologists with varying experience levels in CEUS will interpret exams, enabling us to define these parameters while also quantifying reader variability. In the second aim, we will evaluate the potential improvement to the qualitative assessments of 2D CEUS when fused with the patient's pre-treatment cross-sectional imaging, which we hypothesize will provide better delineation of the initial tumor boundary. In the third aim, we will assess the potential added value of using multi-modality volumetric CEUS for detecting RCC recurrence post ablation and also an advanced Doppler non-contrast technique as an exploratory sub-aim. Finally, we will explore use of quantitative parameters extracted from 2D/3D CEUS exams to determine if this improves the overall performance of CEUS. At the study's conclusion, we hope to address the current limitations in RCC recurrence surveillance imaging with fully powered CEUS study to support clinical adoption, while also addressing prior limitations through the use of multi-modality and quantitative imaging.

项目摘要：肾细胞癌（RCC）占所有癌症的3-5％。局部消融是 建议对T1A肾脏癌的治疗（约占所有RCC的25％），对 由于肾功能降低或固体肾脏而导致的手术候选较差的患者的治疗。 检测复发的启动后成像协议各不相同，但主要依赖于对比增强的计算 在3-12个月间隔间隔3-12个月的时间间隔（CECT）或对比增强的磁共振成像（CEMRI）。 但是，基于检测到消融腔内对比度增强的检测可以检测到浮雕 在这两种方式上都具有挑战性 - 由于大多数复发的成像发现是非特异性的 肿瘤大小的变化，脂肪坏死和疤痕的增强以及钙化的发展 治疗后。此外，由于模式和对比度，这些技术可能会出现问题 禁忌症。作为CECT和CEMRI的替代方案，对比增强超声（CEU）已获得 对各种临床应用的接受。在小型试点研究中，我们的小组证明了 经皮消融后，CEUS以100％灵敏度和 没有不良事件。在令人鼓舞的同时，我们的发现是基于相对较小的样本量，并且 该技术的总体特异性为75-96％，主要是由于无法正确识别 从周围的肾皮质中的消融腔的边界。为了评估CEU的临床承诺，我们 提出一项较大的，全功能的研究，在多个机构中招募患者并使用多模式 成像技术以克服这些局限性并实现临床采用。在我们的第一个特定目标中，我们将 表征两者的灵敏度，特异性，正面和阴性预测价值以及阅读者间的一致性 2D CEU和对比度增强的横截面成像，用于检测消融后复发的RCC；我们将 将长期随访成像和组织病理学的组合用作参考标准，而不是依靠 在Cect或Cemri上。在每个网站上，CEU经验水平都不同的盲目的放射性者将解释 考试，使我们能够定义这些参数，同时还量化了读取器的可变性。在第二个目标中，我们 与患者的融合时，将评估2D CEU的定性评估的潜在改进 预处理横截面成像，我们假设这将提供更好的初始肿瘤的描述 边界。在第三个目的中，我们将评估使用多模式体积CEU的潜在附加值 在消融后检测RCC复发，也是一种高级多普勒非对比度技术作为探索性 子。最后，我们将探索从2D/3D CEUS考试中提取的定量参数的使用以确定 如果这可以提高CEU的整体性能。在研究的结论中，我们希望解决当前 通过完全动力的CEUS研究，RCC复发监视成像的局限性，以支持临床采用， 同时还通过使用多模式和定量成像来解决先前的局限性。