News | April 13, 2012

Rose Breast Center Initiates Study of Laser Therapy for Breast Cancer

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

Related Content

VolparaDensity With Tyrer-Cuzick Model Improves Breast Cancer Risk Stratification
News | Breast Density | May 22, 2019
Research has demonstrated use of Volpara Solutions' VolparaDensity software in combination with the Tyrer-Cuzick Breast...
Partial Breast Irradiation Effective, Convenient Treatment Option for Low-Risk Breast Cancer
News | Radiation Therapy | May 20, 2019
Partial breast irradiation produces similar long-term survival rates and risk for recurrence compared with whole breast...
AI Detects Unsuspected Lung Cancer in Radiology Reports, Augments Clinical Follow-up
News | Artificial Intelligence | May 20, 2019
Digital Reasoning announced results from its automated radiology report analytics research. In a series of experiments...
New Study Evaluates Head CT Examinations and Patient Complexity
News | Neuro Imaging | May 17, 2019
Computed tomography (CT) of the head uses special X-ray equipment to help assess head injuries, dizziness and other...
New Phase 2B Trial Exploring Target-Specific Myocardial Ischemia Imaging Agent
News | Radiopharmaceuticals and Tracers | May 17, 2019
Biopharmaceutical company CellPoint plans to begin patient recruitment for its Phase 2b cardiovascular imaging study in...
Managing Architectural Distortion on Mammography Based on MR Enhancement
News | Mammography | May 15, 2019
High negative predictive values (NPV) in mammography architectural distortion (AD) without ultrasonographic (US)...
Icon Launches New Clinical Trial Patient Engagement Platform
Technology | Patient Engagement | May 14, 2019
Icon plc announced the release of its web-based clinical trial patient engagement platform, to provide patients with...
Radiotherapy After Chemo May Improve Survival in Advanced Hodgkin's Lymphoma Patients
News | Radiation Therapy | May 10, 2019
Patients with advanced Hodgkin's lymphoma who have large tumors at the time of diagnosis may benefit from radiotherapy...
Screening MRI Detects BI-RADS 3 Breast Cancer in High-risk Patients
News | MRI Breast | May 09, 2019
When appropriate, short-interval follow-up magnetic resonance imaging (MRI) can be used to identify early-stage breast...
Novel Artificial Intelligence Method Predicts Future Risk of Breast Cancer
News | Artificial Intelligence | May 08, 2019
Researchers from two major institutions have developed a new tool with advanced artificial intelligence (AI) methods to...