Image-Guided Stereotactic Radiosurgery of Breast Cancer

DESCRIPTION (provided by applicant): Breast cancer is the most prevalent malignancy among women. Its awareness and screening have resulted in the majority of breast cancers being diagnosed in the early-stage, for which breast conservation therapy (BCT) has become the standard of care. BCT consists of a lumpectomy followed by 6-8 weeks of radiation therapy, mostly irradiating whole breast. Although the outcome of BCT is favorable, the invasive and geometrically inaccurate surgery and the lengthy radiotherapy significantly worsen the quality of life for a large population of patients. This Fast Track application aims to develop the key technologies for image-guided SRS of breast cancer, including a dedicated gamma irradiation unit (patent pending), a treatment planning system (TPS), and breast immobilization and localization devices and methods (patent pending). In Phase I of the development (6 months) are to answer one key question: can we reproducibly localize breast cancer for image-guided SRS? We will 1)Develop an MRI compatible couch top for a Siemens MR imager; 2) Develop a breast immobilization cup and stereotactic localization frame that locks on to the couch top; and 3) Study the reproducibility of the breast alignment and the accuracy of localization. The milestones for Phase 1 are the verified methods and devices for reproducibly localizing breast tissue with an accuracy of 1 mm or better. In Phase II (three years), we will complete the development of the other key components and perform system testing. Specifically, we will 1) Develop a dedicated gamma irradiation device and the treatment couch for delivering breast SRS; 2) Develop the treatment planning system (TPS) for gamma radiosurgery of breast cancer; 3) Perform system integration and radiation testing to verify geometric and dosimetric accuracy and safety; and 4) Perform Phase I clinical testing and apply for FDA 510(k) clearance. By the end of the Phase II development, we will have an FDA-cleared complete system that is ready for a Phase II clinical trail in a limited number of institutions. Successful completion of the developments will revolutionize breast cancer care and drastically improve the lives of millions of women inflicted with the disease. Patients with early stage breast cancer can be painlessly and cost-effectively cured by a non-invasive procedure, with unsurpassed cosmesis (no scars).This project aims to develop an image-guided radiation system for the treatment of breast cancer, which is the most prevalent malignancy among women. Successful completion of the proposed developments will revolutionize breast cancer care and drastically improve the lives of millions of women inflicted with the disease.