Predicting Neoadjuvant Chemo Response/Prognosis Using Imaging Biomarkers

使用成像生物标志物预测新辅助化疗反应/预后

• 批准号: 8642609
• 负责人: Min-Ying L. Su
• 金额: $ 48.48万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2018-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8642609
• 关键词: Biological Markers; Blood Vessels; Breast; Cadmium; Cancer Patient; Caring; Cells; Clinical; Clinical Trials; Collaborations; Complex; Data; Data Analyses; Data Set; Detection; Devices; Diagnosis; Diagnostic; Disease; Disease-Free Survival; ERBB2 gene; Early treatment; Enrollment; Ensure; Evaluation; Funding; Gamma Cameras; Goals; Gold; Head; Image; Image Analysis; Imaging Device; In complete remission; Individual; Investigation; Lesion; Magnetic Resonance Imaging; Malignant Neoplasms; Mammography; Measures; Metabolic; Methods; Modality; Molecular; Monitor; Morphology; Negative Finding; Neoadjuvant Study; Neoadjuvant Therapy; Operative Surgical Procedures; Paper; Pathologic; Patients; Performance; Phenotype; Positron; Prognostic Marker; Publishing; ROC Curve; Recurrence; Regimen; Research; Residual Tumors; Residual state; Resolution; Role; Staging; Surgical Oncology; System; Therapeutic; Therapy Evaluation; Time; Tissues; Toxic effect; Tumor Subtype; Zinc; base; breast cancer diagnosis; breast density; chemotherapy; clinical application; clinical practice; density; design; detector; diagnostic accuracy; effective therapy; follow-up; imaging modality; improved; interest; malignant breast neoplasm; meetings; molecular imaging; novel; outcome forecast; predictive modeling; prognostic; prospective; public health relevance; response; screening; success; symposium; treatment response; tumor; uptake

DESCRIPTION (provided by applicant): The optimal goal of neoadjuvant chemotherapy (NAC) for breast cancer is to achieve pathologic complete response (pCR) with the least toxicity. As more effective therapies become available, one challenge is how to evaluate the response of tumor in a timely manner, so an optimal regimen can be given to the patient. Reliable imaging methods that can monitor and predict NAC response are critically needed. In addition to therapy response monitoring, imaging parameters are associated with phenotype of cancer and may be used as prognostic markers. We have been performing NAC studies for close to 10 years, and in this renewal we will continue to develop and validate imaging markers for evaluating and predicting therapeutic response, as well as for predicting prognosis. Three aims are proposed. Aim-1 will follow all previously enrolled NAC patients since 2003 (more than 180 patients) to obtain their prognostic information. Other than previously analyzed imaging parameters, two novel imaging markers that are shown to have prognostic value, i.e. the change of breast density (fibroglandular tissue volume) and the stromal tissue contrast enhancement, will be analyzed using a comprehensive quantitative method developed by us. The primary analysis is to use imaging parameters to predict local recurrence, but the disease-free and overall survival will be collected and used in exploratory analyses. Aim-2 and -3 will be performed using the prospectively collected data from a new clinical trial to enroll 75 NAC patients into an imaging monitoring study by using a combined MRI and scinti-mammography (MR-SMM) system. Despite of the research interest in investigating the role of complex multi- parametric imaging methods, there is always a need of an easy method that can measure the tumor size accurately; and SMM has a great potential. Aim-2 will compare the diagnostic performance of SMM and MRI at different times before, during, and after NAC. Also, the diagnostic accuracy of the post-NAC residual disease measured by SMM and MRI will be determined by comparing to pathological examination results as the goldstandard. Aim-3 will evaluate the respective and combined ability of MRI and SMM, based on pre-treatment and early changes in the first follow-up imaging, for predicting pathologic complete response (pCR). The diagnostic results obtained using MRI and SMM from tumors of varying stages at different times during NAC will provide important information for establishing the role of a standalone SMM system, as well as the combined MR-SMM system, for management of breast cancer patients.

描述（由申请人提供）：乳腺癌新辅助化疗（NAC）的最佳目标是实现毒性最少的病理完全反应（PCR）。随着更有效的疗法的可用，一个挑战是如何及时评估肿瘤的反应，因此可以给予患者最佳方案。非常需要监视和预测NAC响应的可靠成像方法。除了治疗反应监测外，成像参数还与癌症的表型有关，可以用作预后标记。我们已经进行了NAC研究已有近10年了，在这种续签中，我们将继续开发和验证成像标记以评估和预测治疗反应，以及预测预后。提出了三个目标。 AIM-1自2003年以来将遵循所有先前入学的NAC患者（超过180名患者），以获取其预后信息。除了先前分析的成像参数外，还将使用美国开发的全面定量方法分析了两个新型成像标记，即具有预后值的两个新型成像标记，即乳腺密度的变化（纤维界组织体积）和基质组织对比度增强。主要分析是使用成像参数来预测局部复发，但是将收集无病和整体存活率，并将其用于探索性分析。 AIM-2和-3将使用新的临床试验的前瞻性收集数据进行，以使用合并的MRI和SCINTI摄影（MR-SMM）系统招募75名NAC患者进入成像监测研究。尽管研究了研究复杂多参数成像方法的作用的研究兴趣，但总是需要一种简单的方法来准确测量肿瘤大小。 SMM具有很大的潜力。 AIM-2将比较在NAC之前，期间和之后的不同时间SMM和MRI的诊断性能。同样，通过将SMM和MRI测量的NAC后残留疾病的诊断准确性将通过将病理检查结果与金色标准进行比较来确定。 AIM-3将根据第一次随访成像的预处理和早期变化来评估MRI和SMM的各自和组合能力，以预测病理完全反应（PCR）。在NAC期间，在不同时间的不同阶段的MRI和SMM获得的诊断结果将为建立独立的SMM系统以及合并的MR-SMM系统的作用提供重要信息，以管理乳腺癌患者的管理。