Could Dedicated Breast PET Predict Multifocality?

描述(由申请人提供)： 计划进行一项分两个阶段的研究，以验证使用专用乳腺PET设备的功能性乳腺成像是否可以在手术前发现和确认乳腺癌的多焦点和/或多中心。掌握多病灶和/或多中心知识的外科医生将从更合理的术前计划中受益。现有的检测多灶性和多中心性的方法阳性预测价值有限，或者难以指导活检以确定指标病变之外的可疑区域。第一阶段将为第二阶段奠定基础，通过展示使用该设备的活检指导将在检测癌症方面具有足够高的阳性预测价值，从而保证对该设备进行最终的第二阶段研究。第二阶段是一项前瞻性计划的临床试验，测试专用乳腺PET设备检测多焦点和/或多中心性区域的能力，这项试验的黄金标准证据将是使用该设备进行靶向可疑病变(指标癌症除外)的核心活检的组织病理学。第二阶段研究的目的是确定多焦点存在的阳性预测值大于预定的下限值(根据先前相关的公共卫生决定而选择)。已经承诺为该SBIR项目的所有阶段提供相应的私人资金。

DESCRIPTION (provided by applicant): A two-phase study is planned to validate whether functional breast imaging with a dedicated breast PET device could detect and confirm breast cancer multifocality and/or multicentricity prior to surgery. Surgeons armed with knowledge about multifocality and/or multicentricity would benefit through more rational pre-surgical planning. Existing methods of detecting multifocality and multicentricity have limited positive predictive value, or have difficulty in guiding biopsy to confirm suspected regions outside the index lesion. Phase I will lay the foundation for Phase II, by demonstrating that biopsy guidance with the device would have a sufficiently high positive predictive value in detecting cancer for an index cancer lesion to warrant proceeding to a definitive Phase II study of the device. Phase II is a prospectively-planned clinical trial testing the ability of the dedicated breast PET device to detect areas of multifocality and/or multicentricity, The gold-standard proof in this trial will be the histopathology of core biopsies of suspicious lesions (other than the index cancer) targeted using the device. The Phase II study is designed to establish that the positive predictive value for the presence of multifocality is greater than a predetermined lower-bound value (selected on the basis of prior relevant public-health determinations). Matching private funds are already committed for all phases of this SBIR project.