Prior to this confirmatory pivotal study, the multicenter Br-002 feasibility study was completed. 98% of tumors less than or equal to 15mm were completely ablated in one procedure.This study will evaluate Novilase for the focal destruction of malignant tumors of the breast that are less than or equal to 15 mm against a performance goal for the standard of care, lumpectomy. The ASBrS' goal of less than 20% retreatment by 2020 was selected as a representative performance goal, i.e., 80.0%, and is consistent with published effectiveness rates for lumpectomy.
Females, aged 18 years and older
Able to give written informed consent herself
Definitive pathologic diagnosis by needle core biopsy
Unifocal malignant tumor (T1a-c, N0-1, M0) that does not exceed 15 mm in longest dimension and measures at least 5 mm away from the skin and chest wall, or can be moved at least 5 mm away from the skin and chest wall by injection of saline or local anesthetic
Subject younger than 18 years of age
Pregnant or breast-feeding
Tumor poorly visualized by ultrasound or x-ray mammography imaging
Contraindications to administration of gadolinium-based contrast agent, including: prior allergic reaction to a gadolinium-based contrast agent, moderate to end-stage kidney disease, and/or acute or chronic severe renal insufficiency (Glomerular filtration rate (GFR) <30ml/min/1.73 sq. meters)
Single group
Novilase Laser ablation
DeviceImage-guided, percutaneous laser ablation of breast tumors
Percentage of target tumors completely ablated in one procedure
Efficacy: Rate of complete ablation by Novilase laser ablation
Frequency of adverse events (categorized using the NCI Common Terminology for Adverse Events (CTCAE) v4.0 guidelines) post-laser ablation and post-surgery
Safety: frequency of AEs
Patient reported rate of return to activities of daily living post-laser ablation and post-surgery
Rate of recovery
Physician reported cosmetic satisfaction, utilizing the 4-point scoring system of breast cosmesis in protocol (e.g., excellent, good, fair, poor) post-laser ablation and post-surgery (4-6 weeks)
Post-procedure cosmetic satisfaction
Health related quality of life outcome measures at three timepoints via EORTC QLQ-C30 & QLQ-BR23 questionnaire (baseline and 4-6 weeks post-laser ablation and post-surgery)
Health-related quality of life outcome measures
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