Nonlinear Microscopy for Surgical Evaluation in Breast Cancer

This trial tests a new imaging tool called a nonlinear microscope (NLM) to assist during breast cancer surgery. The goal is to use the NLM to examine the edges of removed tissue during a lumpectomy, potentially avoiding additional surgeries if cancer is later found at the edges. Participants will undergo surgery either with or without this new imaging. The trial seeks women scheduled for breast cancer surgery who have had a biopsy showing invasive breast cancer or DCIS (a type of non-invasive cancer). As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance surgical outcomes for future patients.

The trial protocol does not specify whether you need to stop taking your current medications. However, it does exclude those who have had any systemic neoadjuvant (preoperative) therapy between the core biopsy and lumpectomy.

Research has shown that a special imaging technique called nonlinear microscopy has been safely used to examine breast and rectal cancer tissues. These studies found it to be very accurate in diagnosing these cancers, with no harmful effects reported. In simpler terms, this imaging method has been used during surgery without causing any negative side effects.¹²³⁴⁵

Researchers are excited about the use of nonlinear microscopy in breast cancer surgery because it offers a new way to evaluate surgical margins in real-time. Unlike standard lumpectomy procedures, which rely on post-surgical pathology to detect any remaining cancerous tissue, nonlinear microscopy provides instant imaging of excised tissue. This technique could potentially allow surgeons to identify and remove residual cancer right away, reducing the need for additional surgeries and improving patient outcomes.

Research has shown that nonlinear microscopy (NLM), which participants in this trial may receive, is a promising tool for examining breast tissue during surgery. Studies have found that NLM can quickly create images similar to those seen under a regular microscope, without needing to prepare the tissue first. This allows doctors to check in the operating room if cancer cells are near the edges of the removed tissue. If cancer cells are found, more tissue can be removed immediately, potentially reducing the need for another surgery later. Initial findings suggest NLM could improve the success of lumpectomies (breast-conserving surgeries) by helping ensure all cancer is removed. Meanwhile, the control arm of this trial involves standard lumpectomy without NLM imaging.²⁵⁶⁷⁸