Developing DOSI Technology for Monitoring Response To Breast Cancer Chemotherapy

开发用于监测乳腺癌化疗反应的 DOSI 技术

• 批准号: 8652204
• 负责人: Bruce J. Tromberg
• 金额: $ 62.03万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-01-01 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8652204
• 关键词: Adjuvant; Advanced Development; American College of Radiology Imaging Network; Blinded; Boston; Breast; Chemotherapy-Oncologic Procedure; Clinical; Clinical assessments; Decision Making; Development; Devices; Diffuse; Enrollment; Evaluation; Flare; Funding; Goals; Imaging Device; Imaging technology; In complete remission; Individual; Infusion procedures; Lead; Lesion; Malignant Neoplasms; Mammary Gland Parenchyma; Mammary Ultrasonography; Measurement; Measures; Medical; Molecular; Monitor; Multi-Institutional Clinical Trial; Nature; Neoadjuvant Therapy; Oncologist; Operative Surgical Procedures; Optics; Outcome; Oxygen; Oxyhemoglobin; Pathologic; Patients; Performance; Pharmaceutical Preparations; Population; Predictive Value; Primary Neoplasm; Prior Chemotherapy; Procedures; Regimen; Research; Research Design; Scanning; Site; Subgroup; System; Technology; Therapeutic; Time; Tissues; Toxic effect; Tumor Markers; Universities; Work; chemotherapy; clinical decision-making; clinical research site; cost; cost effective; hemodynamics; imaging modality; improved; indexing; insight; instrument; interest; malignant breast neoplasm; meetings; optical imaging; predictive modeling; public health relevance; response; spectroscopic imaging; success; tissue oxygenation; triple-negative invasive breast carcinoma; tumor

Project Summary There is considerable interest in developing new quantitative imaging methods to monitor and predict breast cancer response to neoadjuvant chemotherapy (NAC), both prior to and as early as possible during the course of treatment. Diffuse optical spectroscopic imaging (DOSI) allows patients to be followed from baseline through treatment and surgery with a cost-effective, bedside, handheld scanning probe. In this competing renewal application, we propose to further advance the development of a standardized DOSI technology platform by introducing a new, portable, miniature device (m-DOSI) that has significantly reduced cost and size with equivalent performance compared to existing instruments. m-DOSI scanners will be constructed and delivered to all collaborating clinical sites and up to 150 pre-surgical NAC patients will be evaluated in multi- center studies. Our goal is to establish quantitative DOSI functional endpoints of NAC response that predict patient clinical outcome as measured by pathologic complete response (pCR). In order to optimize the power of DOSI predictions and ease of integration into the clinical work flow, we propose to validate three measurement time-points and DOSI endpoints first discovered in our current funding cycle: 1) Tissue oxygen saturation prior to chemotherapy infusion, 2) Tissue oxyhemoglobin concentration one day following the first infusion, and 3) a Tissue optical index (TOI) at the midpoint of NAC prior to switching drug regimens. Tumor hemodynamics will also be investigated during the first week of therapy. NAC midpoint response is currently undergoing evaluation as part of our American College of Radiology Imaging Network 60-patient multi-center clinical trial (ACRIN-6691) that completed enrollment in March 2013, two months prior to the originally anticipated June 2013 end date. We hypothesize that the combination of pre-therapy and one-day post- infusion measurements with the ACRIN mid-point assessment will provide a more practical and improved approach for managing patients. In order to develop new insight into achieving pCR in the challenging triple negative (TN) breast cancer population we will stratify response by molecular subtype and adjust our multi- endpoint predictive model for the TN subgroup. Finally, we will continue to optimize and improve m-DOSI functionality, standardize clinical measurement and analysis procedures, and evaluate whether m-DOSI can be used with equivalent overall performance by different operators. Our long-term goal is to identify the right combination of quantitative clinical endpoints for informing medical decisions on chemotherapy regimen, duration, and timing of surgery. Ultimately this work is expected to lead to a bedside optical imaging technology that can be used to improve patient outcome by maximizing therapeutic response, minimizing unnecessary toxicity, and optimizing clinical decision-making.

项目摘要 有很大的兴趣开发新的定量成像方法来监测和预测乳房 癌症对新辅助化学疗法（NAC）的反应，在课程中尽早和尽早 治疗。弥漫性光谱成像（DOSI）允许从基线开始遵循患者 通过治疗和手术，具有成本效益的床边，手持式扫描探针。在这个竞争中 续签应用，我们建议进一步推进标准化的DOSI技术的发展 通过引入一种新的，便携式的微型设备（M-DOSI），该平台大大降低了成本和大小 与现有仪器相比，性能等效。将建造M-Dosi扫描仪 将在所有合作的临床部位交付，最多可在多达150名术前NAC患者中进行评估 中心研究。我们的目标是建立NAC响应的定量DOSI功能终点，以预测 通过病理完全反应（PCR）测量的患者临床结果。为了优化功率 DOSI预测和易于整合到临床工作流程中，我们建议验证三个 测量时间点和DOSI端点首先在我们当前的资金周期中发现：1）组织氧气 在化疗之前的饱和度，2）第一天后的一天 输注和3）在切换药物方案之前，在NAC中点的组织光学指数（TOI）。瘤 在治疗的第一周还将研究血液动力学。 NAC中点响应目前是 作为我们美国放射学成像学院网络的一部分，进行评估60参与者 临床试验（Acrin-6691）于2013年3月完成了入学率 预计于2013年6月结束日期。我们假设在治疗前的结合和一日后的结合 ACRIN中点评估的输液测量将提供更实用和改进的 管理患者的方法。为了建立新的见解，可以在具有挑战性的三倍方面实现PCR 阴性（TN）乳腺癌种群我们将按分子亚型分类反应，并调整我们的多种 TN子组的端点预测模型。最后，我们将继续优化和改善M-Dosi 功能，标准化临床测量和分析程序，并评估M-DOSI是否可以是 与不同操作员的总体性能相同。我们的长期目标是确定权利 定量临床终点的结合，用于告知有关化学疗法方案的医疗决策， 手术的持续时间和时间。最终，这项工作有望导致床头光学成像技术 可以用来通过最大化治疗反应，最大程度地减少不必要的方法来改善患者预后 毒性，并优化临床决策。