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%。 T1a 肾癌（约占所有 RCC 的 25%）的推荐治疗方法，对于 治疗因肾功能减退或孤立肾而不适合手术的患者。 用于检测复发的消融后成像方案各不相同，但主要依赖于对比增强计算 每隔 3-12 个月进行一次断层扫描 (CECT) 或对比增强磁共振成像 (CEMRI)。 然而，基于消融腔内对比增强的检测来检测复发可以是 这两种方式都具有挑战性——因为大多数复发的影像学结果都是非特异性的，因为 肿瘤大小的变化、脂肪坏死和疤痕的增强以及钙化的发展 此外，治疗后，由于模式和造影剂的原因，这些技术可能会出现问题。 作为 CECT 和 CEMRI 的替代方案，超声造影 (CEUS) 已经获得了认可。 在小型试点研究中，我们的团队已经证明了以下能力： CEUS 可监测经皮消融后残留和复发的肾细胞癌，敏感性为 100% 虽然令人鼓舞，但我们的研究结果是基于相对较小的样本量，并且 该技术的总体特异性在 75-96% 之间，主要是由于无法正确识别 消融腔与周围肾皮质的边界 为了评估 CEUS 的临床前景，我们 提出一项更大规模、更有力的研究，在多个机构招募患者并使用多模式 成像技术克服这些限制并实现临床应用在我们的第一个具体目标中，我们将。 描述敏感性、特异性、阳性和阴性预测值以及两者的读者间一致性 我们将采用 2D CEUS 和对比增强横截面成像来检测消融后复发的 RCC； 结合长期随访影像学和组织病理学作为参考标准，而不是依赖 在每个站点，具有不同 CEUS 经验水平的盲法放射科医生将进行解释。 考试，使我们能够定义这些参数，同时量化读者的变异性。 将评估 2D CEUS 与患者的融合后定性评估的潜在改进 治疗前横断面成像，我们勇敢地将其提供对初始肿瘤更好的描绘 在第三个目标中，我们将评估使用多模态容积 CEUS 的潜在附加值。 检测消融后 RCC 复发以及先进的多普勒非造影技术作为探索性方法 最后，我们将探索使用从 2D/3D CEUS 检查中提取的定量参数来确定。 如果这能提高 CEUS 的整体性能，在研究结论中，我们希望解决当前的问题。 通过全功能 CEUS 研究支持临床采用的 RCC 复发监测成像的局限性， 同时还通过使用多模态和定量成像解决先前的局限性。