Early Phase 1 Study of 3D Ultrasound Imaging for Breast Cancer Lymph Nodes

What this Trial Is About

This trial studies a new three-dimensional ultrasound 3D-US imaging technology designed to evaluate lymph nodes in patients with breast cancer. The study aims to optimize the 3D-US performance, assess its ability to differentiate benign from malignant lymph nodes, and compare it with conventional two-dimensional ultrasound methods for locating clipped lymph nodes in patients undergoing neoadjuvant chemotherapy. Participants receive the 3D-US imaging as part of the study. Those with a lymph node clip placed and undergoing chemotherapy will have the clipped lymph node imaged before surgery. This is an early phase I diagnostic study focused on improving imaging techniques for breast cancer lymph node evaluation. During the study, participants undergo 3D-US imaging to assist radiologists in diagnosing whether lymph nodes are benign or malignant. The primary outcome measure is the accuracy of lymph node diagnosis by radiologists over a period of up to two years. The study involves imaging before surgery, with ongoing evaluation of the diagnostic performance of the new technology throughout the study duration.

3D Ultrasound for the Imaging of Lymph Nodes in Patients With Breast Cancer