Cancer stage and diagnostic triggers as mortality surrogate to validate supplemental breast imaging use in women with dense breasts

癌症分期和诊断触发因素作为死亡率替代指标，以验证补充乳腺成像在致密乳房女性中的应用

• 批准号: 10528475
• 负责人: Susanna Nila Basappa
• 金额: $ 3.36万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-01-01 至 2023-05-21
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10528475
• 关键词: Advisory Committees; Age; Biopsy; Breast; Breast Cancer Detection; Breast Cancer Risk Factor; Breast Magnetic Resonance Imaging; Cancer Detection; Caring; Cessation of life; Characteristics; Clinic; Clinical; Consent; Consumption; County; Data; Data Set; Detection; Development; Diagnosis; Diagnostic; Diagnostic Imaging; Digital Breast Tomosynthesis; Disease; Early Intervention; Environment; Epidemiology; Frequencies; Future; Goals; Guidelines; Image; Insurance Coverage; Investigation; Lesion; Longitudinal Studies; Malignant - descriptor; Malignant Neoplasms; Mammary Gland Parenchyma; Mammary Ultrasonography; Mammographic screening; Mammography; Mandatory Reporting; Masks; Measures; Methods; Modality; Molecular; Nature; Neoplasm Metastasis; Outcome; Patient Care; Patients; Population; Preventive service; Process; Recommendation; Research; Research Support; Resource-limited setting; Risk; Risk Factors; Scientist; Screening for cancer; Specificity; Survival Rate; Techniques; Testing; Time; Tissues; Training; Woman; breast cancer diagnosis; breast cancer survival; breast density; breast exam; breast imaging; cancer type; career; cohort; cost; data sharing; density; detection method; early screening; efficacy evaluation; evidence base; experience; imaging modality; innovation; interdisciplinary collaboration; malignant breast neoplasm; mortality; new technology; novel; novel strategies; open data; premalignant; prevent; primary endpoint; research and development; routine care; routine screening; screening; supplemental screening; technology validation; tumor; ultrasound

Project Summary The long term goal of this project is to develop a definitive and adequate assessment of the diagnostic potential and non-mortality outcomes of breast cancer screening in supplement to mammography for women with dense breasts. The purpose of achieving this goal is to provide evidence to adjust the current inadequate assessment guidelines that modulate care provided and inform insurance coverage, especially in lower resource settings. Breast density is one of the most significant risk factors for the development of breast cancer, and breast density is mandatorily reported to patients in some respect in 30 states. If information identifying increased risk is provided to patients, options for additional care should be provided simultaneously. Supplemental screening measures developed for use by women with an increased risk for breast cancer include breast ultrasound (US), breast magnetic resonance imaging (MRI), digital breast tomosynthesis (DBT) and molecular breast imaging (MBI). Studies have shown that these modalities have an increased specificity compared to mammography, and in conjunction with mammography have an increased sensitivity for tumors. However, with minimal use and short times from FDA approval for this use, it has not been shown that there has been a significant reduction in mortality with use of these modalities. Longitudinal studies assessing the efficacy of breast cancer mortality mitigation are thought to be necessary to show benefit of these modalities, but are costly and time consuming. Therefore, other methods for assessing the utility and benefit of novel technology are required, and will allow for more efficient implementation of technologies that prove beneficial. Regardless of current guidelines with insufficient evidence to recommend use of novel technologies, the Mayo Clinic is in the process of implementing use of screening DBT and MBI in routine care for patients who are the most likely to benefit from these modalities; those who are at increased risk of breast cancer. The Mayo Clinic also has a 27 county wide data sharing effort, the Rochester Epidemiology Project, which allows data abstraction from all patients consenting to EMR research. To that end, the purpose of this proposal is to characterize diagnostic potential (Aim 1) and non-mortality outcomes (Aim 2) for these modalities in order develop a method of assessment independent of direct mortality reduction, by using stage and symptomaticity at time of diagnosis in a setting with the capacity to support this research. Completion of these aims may provide a framework and evidence for the utility and more efficient implementation of new technologies in cancer detection, potentially circumventing the need for longitudinal mortality-based studies. The interdisciplinary collaboration and training environment engaged in the progress of this project will support the applicant’s development and research experience, and will help drive her career as a future clinician scientist.

项目摘要 该项目的长期目标是对诊断的确定评估 乳腺癌筛查为女性乳腺摄影补充剂的潜在和非损害结果 乳房密集。实现这一目标的目的是提供证据以调整当前的不足 评估指南调节提供的护理并为保险提供信息，尤其是在较低的情况下 资源设置。乳房密度是乳房发展的最重要危险因素之一 癌症和乳房密度在30个州的某些方面强制向患者报告。如果信息 确定患者提供了增加的风险，应简单提供额外护理的选择。 为乳腺癌风险增加的女性而制定的补充筛查措施 包括乳房超声（US），乳腺磁共振成像（MRI），数字乳房合成（DBT） 和分子乳房成像（MBI）。研究表明，这些方式具有更高的特异性 与乳房X线摄影相比，与乳房X线摄影结合使用，对肿瘤的敏感性增加。 但是，随着FDA批准的最少使用和此用途的短时间，尚未证明那里 通过使用这些方式，死亡率已大大降低。纵向研究评估 人们认为降低乳腺癌死亡率的功效是必要的 但是昂贵且耗时。因此，评估新颖的效用和利益的其他方法 需要技术，并且将允许更有效地实施证明有益的技术。 不管目前的准则没有足够的证据建议使用新技术，蛋黄酱都 诊所正在实施使用筛查DBT和MBI在常规护理中的使用 最有可能从这些方式中受益；那些患乳腺癌风险增加的人。梅奥诊所 还有27个县广泛的数据共享工作，罗切斯特流行病学项目，该项目允许数据 所有同意EMR研究的患者的抽象。为此，该提议的目的是 表征诊断潜力（AIM 1）和非损害结果（AIM 2），以按顺序 通过使用阶段和症状，开发一种独立于直接死亡率的评估方法 在诊断时，在支持这项研究的能力的环境中。这些目标的完成可能 提供了一个框架和证据，证明了新技术的实用性和更有效地实施 癌症检测，有可能规避对基于纵向死亡率的研究的需求。 参与该项目进步的跨学科合作和培训环境将支持 申请人的发展和研究经验，并将有助于推动她作为未来临床科学家的职业。