Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors

This trial is testing a laser treatment called Novilase as a way to destroy small breast tumors using focused heat, without the need for surgical removal, in women with early-stage breast cancer. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with an early-stage breast cancer (T1, no more than 15mm in size, and not yet spread to distant parts of the body) - Your tumor is clearly visible on ultrasound or mammogram - Your tumor is at least 5mm away from the skin and chest wall - Your tumor has a small amount (less than 25%) of ductal spread within the tissue - You do not have serious other illnesses affecting your life expectancy - You weigh 300 lbs. (136 kg) or less - You agree to follow up with standard radiation or adjuvant therapy afterward **You may NOT be eligible if...** - You are pregnant or breastfeeding - Your tumor cannot be clearly seen on ultrasound or mammogram - You have moderate to severe kidney disease or an allergy to MRI contrast dye (gadolinium) - You have a pacemaker or other metal implants that prevent MRI - You have severe asthma - Your tumor is larger than 15mm or has a large intraductal component - Your cancer is advanced, is a rare type (lobular, sarcoma, Paget's), or you are known to carry a BRCA gene mutation Talk to your doctor to see if this trial is right for you.