Breast cancer is the most frequent malignant tumor in women. Despite mastectomies are increasing, breast conservative surgery remains the standard in breast cancer treatment.
There is still no consensus regarding an adequate resection margin. Re-intervention is required in 20-40% in case of positive margins at histological finding. The essential aim of conservative surgery is to maintain oncological safety associated to an acceptable cosmetic result. It is obvious that it brings major problems in terms of local recurrence which is the reason why it is mandatory to find the most accurate system to avoid positive resection margins. Positive margins have a strong impact on local recurrences, disease free survival and overall survival.
The aim of our study is to evaluate the usefulness of intraoperative tomosynthesis in order to obtain a tumor-free margin section in unique non-multicentric lesions. This could reduce the number of R1 patients better than the 2D intraoperative system.
Including criteria are patients with non-palpable lesions ,any age, excluding patients who undergo mastectomies. Every specimen is marked with stitches and metal clips to identify the resection margins. Tomosynthesis is performed in the OR with Kubtec Mozart, using the standard tomosynthesis technique, which generates multiple low-dose projection images over a 30-degree arc and were reconstructed into a series of 1-mm sections to create a set of parallel slices.
For every specimen will be considered the radiologic distance between tumor margin and resection margin and then verified with the hystological finding. The primary endpoint is to highlight the number of R1 patients and re-intervention rate, comparing it to the number of R1 patients identified with the 2D system.
Nowadays the systems available to detect the real extension of neoplasms are still lacking, specifically for non-palpable lesions, that is why using an affordable intraoperative detecting system can be useful in defining the correct tumor area and avoid positive margins and local recurrence.
The primary endpoint of the study is to evaluate the feasibility and effectiveness of the Mozart system (Kubtec Medical Imaging, Stratford, CT, USA) compared with the standard technique. This new method can be proposed as a gold standard to reduce R1 patients, re-intervention rate and local recurrence in order to improve
disease free survival, overall survival and quality of life. As secondary endpoint to improve the quality of the images and the rendering view with the possibility of tridimensional specimen reconstructions that are still not feasible with the current device.