A Phase II Feasibility Study to Assess the Use of SIR-Sphere in Patients With Breast Cancer Who Have Chemotherapy-Resistant Disease in the Liver
Patient must pass an MAA angiography study to detect abnormal shunting of the vessels to the
lungs and stomach. Shunting of the radiation seeds to these areas, if an abnormality exists
would be harmful.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary: Assessment of the feasibility of SIRT treatment as measured by tumor response in the treated labe/s of the liver.Assessed by CT scan and measurement Secondary Response: Assessment of treatment toxicity. Assessed by examination and blood work.
Patients will be followed for 5 years or Progressive disease in the treated liver or until such time as systemic therapy is needed for disease in other organs which will affect tumor response in the liver.
ALison R Calkins, MD
St. Joseph's Hospital, Department of Radiation Therapy
United States: Food and Drug Administration
|St. Joseph's Hospital, Department of Radiation Therapy||Tampa, Florida 33607|