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: 8788694
• 负责人: Bruce J. Tromberg
• 金额: $ 58.75万
• 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/8788694
• 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; Health; 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; Multicenter Studies; 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; Technology; Therapeutic; Time; Tissues; Toxic effect; Tumor Markers; Universities; Work; chemotherapy; clinical decision-making; clinical research site; cost; cost effective; hemodynamics; imaging modality; imaging system; improved; indexing; insight; instrument; interest; malignant breast neoplasm; meetings; optical imaging; predictive modeling; quantitative imaging; response; spectroscopic imaging; success; temporal measurement; tissue oxygenation; triple-negative invasive breast carcinoma; tumor; 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; Health; 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; Multicenter Studies; 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; Technology; Therapeutic; Time; Tissues; Toxic effect; Tumor Markers; Universities; Work; chemotherapy; clinical decision-making; clinical research site; cost; cost effective; hemodynamics; imaging modality; imaging system; improved; indexing; insight; instrument; interest; malignant breast neoplasm; meetings; optical imaging; predictive modeling; quantitative imaging; response; spectroscopic imaging; success; temporal measurement; tissue oxygenation; triple-negative invasive breast carcinoma; tumor

DESCRIPTION (provided by applicant): 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 o 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.

描述（由申请人提供）：在治疗过程中，无论是在治疗过程中还是尽可能尽早，都在开发新的定量成像方法以监测和预测乳腺癌对新辅助化学疗法（NAC）（NAC）的反应。弥漫性光谱成像（DOSI）允许患者通过基线和手术进行经济高效的床边，手持式扫描探针。在此相互竞争的续订应用程序中，我们建议通过引入一种新的，便携式的微型设备（M-DOSI），进一步推动标准化的DOSI技术平台的开发，该设备（M-DOSI）显着降低了与现有工具相比，成本和大小相同的性能。 M-DOSI扫描仪将被构造并交付到所有合作的临床部位，并将在多中心研究中评估多达150名手术前NAC患者。我们的目标是建立NAC反应的定量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DOSI预测的功能，并易于整合到临床工作流程中，我们建议在我们当前的资金周期中首先发现的三个测量时间点和DOSI终点：1）在化学疗法输注之前的组织氧饱和度，2）在第一天进行中的氧气浓度，并在第一天进行互及3）。转换药物方案。在治疗的第一周，还将研究肿瘤血液动力学。 NAC中点响应目前正在评估，这是我们美国放射学会网络60-Patient多中心临床试验（ACRIN-6691）的一部分，该试验于2013年6月预期的2013年6月结束日期之前的两个月完成了2013年3月的入学人数。我们假设，在疗法和一日输注后测量与ACRIN中点评估的结合将为治疗患者提供更实际和改进的方法。为了发展新的洞察力，可以在具有挑战性的三重阴性（TN）乳腺癌种群中实现PCR，我们将通过分子亚型对响应进行分层，并调整TN亚组的多端点预测模型。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，并评估是否可以通过不同运算符的总体性能使用M-DOSI。我们的长期目标是确定定量临床终点的正确组合，以告知医疗决策o化学疗法方案，持续时间和手术时间。最终，预计这项工作将导致一种床边光学成像技术，该技术可通过最大化治疗反应，最大程度地减少不必要的毒性并优化临床决策来改善患者的结局。