Product:

• Nanoparticle-based fluorescence optical imaging agent that will allow the surgeon to identify breast tumor margins intraoperatively

Problem:

According to the American Cancer Society in 2009, there were 192,370 new cases of invasive breast cancer and 40,170 cases resulted in death in the U.S. alone. Globally, it is estimated that there are 1.3 million new cases per year. The chance of a woman having invasive breast cancer is over 12%, and the chance of dying from the disease is close to 3%. In the U.S. there are approximately 150,000 lumpectomy (followed by radiation) procedures performed each year. The risk of cancer recurrence is approximately 7.3%, meaning that there are about 11,000 recurrent cases per year in the U.S. Additionally, a majority of surgeon-estimated margins for lumpectomy specimens are found to be compromised (less than 10 mm from the tumor edge) when viewed by pathology under frozen section analysis. In these cases, intraoperative re-excision or additional margins must be resected, creating added operative time and potential morbidity to the patient from prolonged anesthesia. The rate of recurrence is so high due to current technology which is limited to needle, wire or radioactive “seed” localization of the tumor and later pathological examination to determine if additional resection is necessary.

NanoScale Solution:

NanoScale Corporation, in collaboration with Kansas State University, has developed an optical contrast agent that for the first time would provide cancer surgeons the ability to accurately and safely determine tumor margins intraoperatively, without the time-delays and potential inaccuracies of ex-vivo tumor radiographs to document completeness of resection and minimize removal of normal tissue. This novel application would decrease patient morbidity, improve breast conservation rates from better margin assessment, and reduce operative time and cost. The typical cost of treatment of recurring breast cancer cases is between $11,000 and $19,000 depending on the specific scenario. This amounts to a total cost of treatment following recurrent cases of between $120M-$210M annually. NanoScale’s technology would have a substantial impact in eliminating a significant fraction of this cost. NanoScale’s improved intraoperative margin identification will enable surgeons to remove all pathological tissue in one operation, without removing healthy tissue, thus facilitating breast reconstruction.

Competitive Advantage:

Current technology is limited to needle, wire, or radioactive “seed” localization of the tumor, with later pathological (microscopic) examination to determine if additional resection is necessary. NanoScale’s improved intraoperative margin identification will enable surgeons to remove all pathological tissue in one operation, without removing healthy tissue, thus facilitating breast reconstruction.

• Adaptability to basically all solid tumors and to the detection of sentinel lymph nodes
• Synergy with mammography, MRI and ultrasound contrast agents (simultaneous X-ray (15x more specific), MRI (T₁ and T₂) and ultrasound)
• Reduction in the number of intraoperative re-excisions and local recurrence rates
• Improved breast conservation rates
• Decrease in patient mortality
• Reduction in operative time and costs
• Safety (no radioactive compounds) and low toxicity (10x less toxic per imaging than Feridex)
• Stability for more than 1 year, as powder under Ar (easy distribution)
• Fluorescence only when activated by a cancer-specific biochemical process
• High spatial resolution (1 mm² and sensitivity, 10^-14 moles)
• Real time tumor and/or metastases detection under 1 mm in size in clinical settings
• Adaptability to existing surgical equipment