A Multicenter “Ablate and Resect” Study of Novilase® Interstitial Laser Therapy for the Ablation of Small Breast Cancers

Inclusion Criteria:

Females 18 to 80 years of age
Tumor is well visualized through x-ray mammography or ultrasound imaging and amenable to image guidance therapy (a tumor which is well visualized through imaging can be identified from surrounding breast tissue and does not have margins
obscured by other structures or artifacts on the images)
Tumor must be well visualized (as defined above) on MRI
Definitive pathologic diagnosis by needle core biopsy
Unifocal malignant tumor that does not exceed 20mm in diameter and measures at least 5mm away from the skin and chest wall
Cluster of microcalcifications that do not exceed 10 mm in diameter and measures at least 5mm away from the skin and chest wall
Subjects with or without palpable lymph nodes
Subjects with mammographic appearance of overall dense parenchymal tissue may be included, as long as a clearly evident marker is present at tumor site
Subjects with less than 25% intraductal component
Subject has no clinically significant co-morbidities (i.e. chronic illnesses existing simultaneously with and usually independent of breast cancer) that affect life expectancy. Subject has given written informed consent
Subject agrees to comply with follow up visits

Exclusion Criteria:

Subjects younger than 18 years of age
Pregnant or breast-feeding women
Tumors poorly visualized by x-ray mammography or ultrasound imaging
Women who are morbidly obese (>300 lbs)
Acute or chronic severe renal insufficiency (Glomerular filtration rate (GFR) <30ml/min/1.73 sq.meters)
Moderate to end-stage kidney disease and a history of severe asthma or allergies
Tumors measuring greater than 20mm in diameter
Subjects with advanced stage breast cancer
Subjects with prior history of cancer in the ILT treated breast
Subjects with recurrent breast cancer
Subjects with lobular neoplasm, metastatic carcinoma to breast, sarcoma, Phylloides tumor, or Paget's disease
Subjects with benign vascular tumor
Subjects with benign lesions such as fibroadenoma, atypical ductal hyperplasia, sclerosing adenosis, Papilloma, fibrocystic disease of breast
Subjects with DCIS with microinvasion
Subjects with a cluster of microcalcifications whose diameter is larger than 10 mm.
Subjects with extensive intraductal component and other characteristics not well visualized by imaging studies
Subjects who are BRCA positive.
Inability to lie prone or supine for one hour
Currently participating or enrolled in another investigational treatment, device or drug study through follow up
Undergoing concurrent neoadjuvant therapies for breast cancer
Cardiac pacemaker or other metallic implants which would prevent patient from safely undergoing MRI scan