Could Dedicated Breast PET Predict Multifocality?

描述（由申请人提供）： 计划进行一项两阶段研究，以验证使用专用乳腺PET设备进行的功能性乳腺成像是否可以在手术前检测和确认乳腺癌的多灶性和/或多中心性。掌握多焦点和/或多中心知识的外科医生将通过更合理的术前计划受益。现有的检测多灶性和多中心性的方法具有有限的阳性预测值，或者难以引导活检以确认指示病变以外的可疑区域。I期将为II期奠定基础，通过证明使用该器械的活检引导在检测指示癌症病变的癌症方面具有足够高的阳性预测值，以保证继续进行该器械的确定性II期研究。II期是一项前瞻性计划的临床试验，旨在测试专用乳腺PET设备检测多灶性和/或多中心性区域的能力。本试验的金标准证据将是使用该设备靶向的可疑病变（索引癌症除外）的核心活检的组织病理学。II期研究的目的是确定多灶性存在的阳性预测值大于预定的下限值（根据之前相关的公共卫生确定进行选择）。配套的私人资金已经承诺用于该SBIR项目的所有阶段。

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.