Minimally invasive laser treatment for the removal of small breast tumors

Breast cancer (mammary carcinoma) is a malignant disease of the mammary gland tissue characterized by the uncontrolled proliferation of mammary gland cells. If detected early—for example, as a small, localized tumor without metastases to other parts of the body—the chances of a cure are good. The standard treatment in such cases is a procedure known as breast-conserving surgery, in which the tumor is completely removed from the breast tissue. This is usually followed by radiation therapy and, if necessary, adjuvant drug therapy. Novilase® laser therapy represents a possible alternative to surgery. In this procedure, a fine probe is inserted into the tumor under imaging guidance (e.g., ultrasound). The tumor is destroyed through targeted heat application via this probe.

The aim of this study is to investigate the efficacy and safety of Novilase® laser therapy. All patients first undergo a magnetic resonance imaging (MRI) scan to determine the exact location and nature of the tumor. Laser treatment is then performed. After approximately 4 to 6 weeks, another MRI is performed to verify whether the tumor has been completely removed. In addition, the affected tissue is surgically removed and examined histologically. The treatment is considered successful if it is shown that the tumor was completely destroyed by the laser treatment, ideally in at least 88% of the patients. Depending on the physician’s recommendation, additional radiation therapy or drug therapy—as in the standard treatment—is then administered.

Eligible participants are adult women with a single, malignant breast tumor no larger than 15 mm. The tumor must be clearly visible on MRI and ultrasound and must be located at least 5 mm from the skin or chest wall. Additionally, the tumor must not contain a high proportion of so-called intraductal components. Women with a specific form of breast cancer (so-called triple-negative breast cancer), those with tumors that are difficult to visualize on imaging studies or larger than 15 mm, as well as pregnant or breastfeeding women or patients with contraindications to MRI, are excluded.