Evaluation of 3D MRI-Based Quantitative Breast Density for Chemoprevention

基于 3D MRI 的定量乳腺密度对化学预防的评估

• 批准号: 7663554
• 负责人: Jeon-Hor Chen
• 金额: $ 7.64万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2011-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7663554
• 关键词: 3-Dimensional; Adipose tissue; Adverse effects; Aftercare; Algorithms; Blood Clot; Blood coagulation; Breast; Breast Cancer Risk Factor; Calibration; Cancer Patient; Chemistry; Chemoprevention; Clinical; Computer Assisted; Contralateral; Control Groups; Data; Development; Diagnosis; Early Diagnosis; Enrollment; Estrogen receptor positive; Evaluation; Event; Film; Follow-Up Studies; Foundations; Future; Goals; High Risk Woman; Hormonal; Image; Incidence; Individual; Lead; Magnetic Resonance Imaging; Malignant Neoplasms; Mammographic Density; Mammography; Measurement; Measures; Medicine; Methods; Monitor; NIH Program Announcements; Nature; Operative Surgical Procedures; Patients; Pharmaceutical Preparations; Population Study; Positioning Attribute; Postmenopause; Premenopause; Prevention; Radiation therapy; Recruitment Activity; Replacement Therapy; Reporting; Research; Research Methodology; Risk; Risk Assessment; Risk Factors; Roentgen Rays; Second Primary Cancers; Source; Specific qualifier value; Surrogate Markers; Tamoxifen; Techniques; Technology; Testing; Three-Dimensional Image; Time; Translational Research; Uterine Cancer; Variant; Woman; Work; base; breast cancer diagnosis; breast density; cancer risk; density; imaging modality; malignant breast neoplasm; new technology; novel; patient population; pressure; risk benefit ratio; soft tissue; standard of care; success

DESCRIPTION (provided by applicant): Mammographic density is well accepted as a risk factor for breast cancer. Many drawbacks exist for mammographic density measurements. Mammography is a projection 2D image, not a 3D image. Mammography suffers from imperfect calibration of parameters and variation in film exposure factors. Changes in exposure, compression, and processor chemistry may influence the background density of the film and potentially the measured breast density in each study, making comparison between subjects or longitudinally unreliable. Density measured on breast MRI has a great potential to provide a sensitive, quantitative method for evaluating breast density. MRI provides a great soft tissue contrast distinguishing between fibroglandular and fatty tissues; also it provides the 3-dimensional breast coverage; thus is an optimal imaging modality for evaluating fibroglandular density. Despite several studies used MRI aiming for developing automated computer-aided mammographic density analysis, there is little effort to develop a reliable method for monitoring the change breast density over time for individual woman. A quantitative MRI-based measure of "percent fibroglandular density" may be used to evaluate the changes induced by the chemoprevention drug. Secondary chemoprevention is commonly used for high-risk women who already had diagnosis of breast cancer. Incidence of breast cancer in the contralateral breast increases after treatment of breast caner. The cumulative incidence at 20 years was 15.4%. Tamoxifen was proven effective, and prescribed widely to pre-menopausal patients diagnosed with estrogen receptor positive breast cancer. Despite the promising results, whether to offer chemoprevention, or which drug to give, is solely based on population study results. There is not an individualized method that can be used for a woman to determine whether the chemoprevention is working on her, thus is beneficial over the possible side effects and risks. In this application we propose to use our developed 3D MRI-based quantitative breast density evaluation method to test the specific hypothesis that secondary chemoprevention with tamoxifen (for pre-menopausal women) will reduce the breast density compared to controls. We will also follow all enrolled subjects for future events of breast cancer development. When the data is available we will be able to directly test the hypothesis that reduced density is correlated with lower future cancer events. Two aims are proposed in this study 1) Aim-1: To evaluate the changes of breast density in pre-menopausal women receiving tamoxifen vs. controls using MRI-based analysis. 2) Aim-2: To obtain mammograms of all patients for density analysis, and compare the results to that based on MRI in terms of measurement variation and changes of density between tamoxifen vs. controls.

描述（由申请人提供）： 乳房X光密度被广泛认为是乳腺癌的危险因素。乳房X线密度测量存在许多缺点。乳房 X 线摄影是投影 2D 图像，而不是 3D 图像。乳房X光检查存在参数校准不完善和胶片曝光系数变化的问题。曝光、压缩和处理器化学成分的变化可能会影响胶片的背景密度，并可能影响每项研究中测量的乳房密度，从而使受试者之间或纵向上的比较变得不可靠。乳腺 MRI 测量的密度很有可能为评估乳腺密度提供灵敏的定量方法。 MRI 可提供良好的软组织对比度，区分纤维腺组织和脂肪组织；它还提供 3 维乳房覆盖；因此，这是评估纤维腺体密度的最佳成像方式。尽管有几项研究使用 MRI 旨在开发自动化计算机辅助乳房 X 光密度分析，但几乎没有努力开发一种可靠的方法来监测个体女性乳房密度随时间的变化。基于 MRI 的定量测量“纤维腺体密度百分比”可用于评估化学预防药物引起的变化。二级化学预防通常用于已诊断出乳腺癌的高危女性。乳腺癌治疗后，对侧乳房的乳腺癌发病率会增加。 20年累积发病率为15.4%。他莫昔芬被证明有效，并广泛用于诊断患有雌激素受体阳性乳腺癌的绝经前患者。尽管结果有希望，但是否提供化学预防或给予哪种药物，完全取决于人群研究结果。目前还没有一种个体化的方法可以让女性确定化学预防是否对她有效，因此对于可能的副作用和风险来说是有益的。在此应用中，我们建议使用我们开发的基于 3D MRI 的定量乳腺密度评估方法来测试特定假设，即与对照相比，使用他莫昔芬（针对绝经前女性）进行二级化学预防会降低乳腺密度。我们还将跟踪所有登记受试者的乳腺癌发展的未来事件。当数据可用时，我们将能够直接检验密度降低与未来癌症事件减少相关的假设。本研究提出了两个目标 1) 目标 1：使用基于 MRI 的分析来评估接受他莫昔芬治疗的绝经前女性与对照组的乳腺密度变化。 2) 目标2：获得所有患者的乳房X光照片以进行密度分析，并将结果与​​基于MRI的结果在他莫昔芬与对照之间的测量变异和密度变化方面进行比较。