Novilase Trial Enrolling Now
Laser therapy to treat early stage breast cancer.
Columbia University Medical Center is now enrolling patients in a new clinical trial examining the effectiveness of laser therapy to treat early-stage breast cancer. This new research is testing a non-surgical treatment called Novilase® Interstitial Laser Therapy (ILT).
Novilase Breast Therapy is already approved by the FDA for the treatment of breast fibroadenomas, which are the most common form of benign (non-cancerous) breast tumor. This multi-center international clinical trial follows a successful feasibility trial at Rush University (Chicago, IL) using laser to treat breast tumors.
The current study will test the ability of the laser 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. Destroying the tumor with a laser may have advantages including:
- Minimal scarring
- Less chance of infection
- Much shorter recovery time
- Preservation of natural shape (i.e., cosmetic appearance) and feel of the breast
"The goal of the laser treatment is to provide a safe and effective alternative to lumpectomy that is less disruptive to the patient's life in multiple ways," said Margaret Chen, M.D., FACS, who is directing the clinical trial at NYP/Columbia. "A laser treatment is potentially more convenient and less painful, without permanent changes to the woman's breast. This research will help determine if some women with early-stage breast cancer can avoid surgery and access these advantages in the future."
After patients receive 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 research study is entirely voluntary and a patient's decision to join or not to join the clinical research study will not affect any medical benefits.
The clinical trial sponsor, Novian Health Inc., has designed, tested, and patented a minimally invasive device called, Novilase that uses laser energy to destroy tumors. 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.