April 13, 2012 — Novian Health, developer of Novilase Breast Therapy, announced it has begun a multicenter clinical trial on the use of Novilase Interstitial Laser Therapy (ILT) for the destruction of malignant breast tumors. The first facility to participate in the trial is the Rose Breast Center in Denver, under the study direction of Barbara Schwartzberg, M.D.
Novilase ILT is an image-guided, minimally invasive alternative for lumpectomy, used to ablate (destroy) small breast tumors. The new clinical trial is the first stage of a two-stage study as part of a U.S. Food and Drug Administration (FDA) premarket approval (PMA) process. The trial follows a successful, single-center feasibility study on Novilase ILT for treatment of malignant breast tumors. The company said it would soon also begin a similar clinical trial in Europe.
Novian Health has previously received FDA 510(k) clearance for the treatment of breast fibroadenomas, and currently offers Novilase at Rose and other breast centers around the country participating in its ABLATE registry.
This study will evaluate the rate of complete tumor ablation of breast cancers that are up to 2 cm. It will also examine the correlation of the pathology of post-ablation lumpectomy specimens with magnetic resonance imaging (MRI), mammography and ultrasound in detecting any residual tumor.
"The goal of this study is to evaluate whether minimally invasive laser ablation of early-stage breast cancer is as effective as a traditional surgical lumpectomy," said Barbara Schwartzberg, chair of cancer services at Rose Breast Center. "With laser, this may be performed more conveniently, with less pain and with less deformity. I am proud to offer this as an option for patients at the Rose Breast Center, continuing our tradition of providing the latest technologies and treatments."
Novilase ILT may provide women who have early-stage breast cancer with the option of an ablation procedure that could result in a lower rate of residual disease and thus fewer re-treatments, shorter recovery time, minimal scarring or breast deformity. Novilase does not preclude any additional treatment, if necessary, such as the use of radiation therapy and/or systemic adjuvant therapy, as per standard of care.
Given the overall shift to more precise and targeted cancer treatments, many women have an increased expectation for less invasive procedures. Just as needle-core breast biopsy has provided a new alternative to surgical biopsy, Novilase ILT may be another option for women with breast cancer who are considering lumpectomy.
For more information: www.novianhealth.com