Laser Ablation Therapy
“Ablate and Resect” Study of Novilase Interstitial Laser Therapy for Precision Treatment of Small Breast Cancers
NewYork-Presbyterian/Columbia University Medical Center is enrolling patients in a new clinical trial examining the effectiveness of laser therapy to treat early-stage breast cancer.
This multicenter study is testing the ability of Novilase® Interstitial Laser Therapy (ILT) to ablate (destroy) breast cancers that are equal to or less than 2 centimeters in size. Approximately 50% of breast cancer patients are estimated to qualify for inclusion in the study.
Traditionally, early-stage breast cancers have been removed by surgery, i.e., lumpectomy, which can unfavorably affect the look and feel of the breast. Moreover, during lumpectomy it is not possible to perfectly define the extent of the cancer or know precisely which tissue to excise. As a result, 20 to 30% of women require a second lumpectomy to remove remaining cancerous tissue. Even after a second lumpectomy, microscopic remnants may persist, leading to mastectomies in 8% of patients. In contrast, laser therapy is performed under direct ultrasound visualization so that surgeons can see the cancer in real time as they ablate it.
Destroying the tumor with a laser may have advantages including:
- Highly precise treatment done under direct visualization
- Performed in office rather than operating room
- Local rather than sedation or general anesthesia
- Very small incision
- Minimal scarring
- Less chance of infection
- Much shorter recovery time
- Preservation of natural shape (i.e., cosmetic appearance) and feel of the breast
Women with small breast cancers will undergo the ablation procedure prior to surgical excision of their breast cancers. The ablation procedure takes place in an outpatient setting, and is typically completed in 30-60 minutes.
After patients undergo the Novilase procedure, participants will have post-ablation imaging and surgery at or around 28 days following laser ablation. A sentinel lymph node biopsy, if indicated, as part of normal standard of care may be performed at the time of surgery or prior to laser ablation. Following surgery, the patient will proceed with recommended adjuvant or systemic therapy (i.e., radiation and/or chemotherapy). The patient will return for annual follow-up visits with their surgeon.
Taking part in a clinical trial is entirely voluntary and a patient’s decision to join or not to join the trial will not affect any medical benefits. All research-related expenses are paid for by the study sponsor and at no cost to the patients participating. Patients and the insurance company will be responsible only for the standard-of-care procedures and services.