Numerous clinical tests based on invasive ductal carcinoma were performed in seven countries around the world since the MRgFUS was approved by the FDA in 2001. Breastopia Namba Hospital has been participating in the Protocol BC001-BC004, a Internationally founded clinical study.
. We also plan to participate this fall in BC004, a Internationally founded clinical study, and will investigate and review approximately 2100 surgery records from the past. We are also working on creating a new protocol based on using only the MRgFUS when treating local relapse. The participants of such clinical tests include Harvard University’s Brigham and Women’s Hospital, Montreal University’s St. Luc Hospital out of the four institutions in North America; two institutions in Europe, two in the Middle East, and one (Breastopia Namba Clinic) in Asia.


　
　　　　Among the many ways to treat breast cancer, several of
　　　　the most common ones include total excision and lumpectomy
　　　　(partial excision) of the breast. A patient’s applicability for
　　　　the MRgFUS treatment is determined according to the size and type of the tumor.


　　　　　
　　　　*(an FUS-operating computer screen)
　　　　　The green circle, or the “spot”, is used to mark the location of
　　　　　the tumor before it is burned for treatment.
　　　　　The patient’s pulse rate and blood oxygen level are shown
　　　　　on the screen at all times, and the temperature increase
　　　　　of when the fibroid is being “burned” with the ultrasonic waves is also indicated.


　　　

　　　　　　　　　　　*(Before MRgFUS)　　　　　　　　　　　　　　*(After MRgFUS)

　

　　

　　　　　Patients who:

　　　　　　　　*are diagnosed with breast cancer
　　　　　　　　*are applicable for other types of treatment but do not wish
　　　　　　　　　to be treated in such ways
　　　　　　　　*do not experience heart failure (cardiac angina)
　　　　　　　　*have not experienced myocardial infarctions (heart attacks)
　　　　　　　　　within the past six months
　　　　　　　　*have not experienced cerebral thrombosis within the past six months
　　　　　　　　*are applicable for the MRI
　　　　　　　　　　　　(-patients who are allergic to contrast media,
　　　　　　　　　　　　　patients with pacemakers, and
　　　　　　　　　　　　　patients who are claustrophobic
　　　　　　　　　　　　　　　　　　　　　　　are not applicable for the MRI)
　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　…are applicable for the MRgFUS treatment

　　　　　　　　++Applicability for FUS is decided according to the MRI results


　　
　　　　　Apparatus: MRgFUS (Insightec ExAblate 2000)
　　　　　Time required: Approximately three to five hours; once or twice
　　　　　　　　　　　　　　　　　　　　　　　(varies according to the size of the fibroid/tumor)　
　　　　　Insurance: National health insurance is not applicable

　　　　　*Overnight stay at the hospital/clinic is not required.


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