Comparative Research on the Accuracy of Margin Interpretation in Breast-Conserving Surgery for Breast Cancer: Cell Microscopic Imaging and Standard Frozen Pathology

Launched by PEKING UNIVERSITY CANCER HOSPITAL & INSTITUTE · Jun 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to check the edges (called “margins”) of breast tissue removed during breast-conserving surgery for breast cancer. The goal is to see if a special cell imaging method can quickly and accurately tell whether any cancer cells are left at the edges of the removed tissue during surgery. Right now, doctors use a standard method called frozen pathology to do this, but the new imaging technique might be faster or more precise. The study will compare both methods to see which works better in helping surgeons make sure all the cancer is removed.

Women between 18 and 70 years old who have early-stage breast cancer without spread to other parts of the body may be eligible to join. Participants will have breast-conserving surgery as planned, and during the operation, their tissue margins will be checked using both the new imaging method and the standard frozen pathology. After surgery, participants will have follow-up visits over the course of a year to monitor their recovery. This study aims to improve how surgeons confirm cancer removal during surgery, potentially leading to better outcomes and fewer additional treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged between 18 and 70 years old;
• • Clinical or imaging showed a single lesion with no evidence of distant metastasis;
• • No invasion of the skin, subcutaneous tissue, pectoralis major muscle, and nipple-areola complex;
• • Breast cancer patients who are willing to undergo breast-conserving surgery;
• • Subjects voluntarily signed the informed consent form.
• Exclusion Criteria:
• • Allergic constitution;
• • Chest wall or skin invasion, locally advanced breast cancer;
• • Extensive axillary lymph node metastasis (stage ⅢB and above);
• • Patients with severe complications (such as organ dysfunction, immunodeficiency) and poor general condition;
• • Unable to accept general anesthesia or surgical treatment;
• • Participating in other clinical studies that may affect this trial;
• • Patients who cannot send frozen pathology and paraffin pathology specimens for examination during surgery.