Could Dedicated Breast PET Predict Multifocality?

专用乳房 PET 可以预测多灶性吗？

• 批准号: 7059371
• 负责人: JUDITH E KALINYAK
• 金额: $ 78.7万
• 依托单位: NAVISCAN PET SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7059371
• 关键词: X ray; bioimaging /biomedical imaging; biopsy; breast neoplasm /cancer diagnosis; clinical research; clinical trials; female; histochemistry /cytochemistry; imaging /visualization /scanning; mammography; molecular oncology; neoplasm /cancer classification /staging; patient oriented research; positron emission tomography; technology /technique development; women' s health

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.

描述（由申请人提供）： 计划进行两阶段的研究，以验证使用专用的乳化装置的功能性乳房成像是否可以在手术前检测并确认乳腺癌的多焦点和/或多中心。拥有有关多焦点和/或多中心的知识的外科医生将通过更合理的手术前计划受益。现有的检测多焦点和多中心的方法具有有限的积极预测价值，或者难以指导活检以确认指数病变以外的可疑区域。第一阶段将通过证明对该设备的活检指导在检测指数癌病变的癌症方面具有足够高的阳性预测价值来为II期奠定基础，以保证继续进行该设备的确定性II期研究。 II期是一项前瞻性计划的临床试验，该试验测试专用的母乳形装置检测多焦点和/或多中心区域的能力，该试验中的金标准证明将是可疑病变的核心活检组织病理学的组织病理学（除了使用该设备靶向的指数癌）的组织病理学。 II阶段研究旨在确定多焦性的存在的正预测价值大于预定的下限值（根据先前相关的公共卫生确定选择）。该SBIR项目的所有阶段已经投入匹配的私人资金。