Contrast Enhanced Digital Mammography for Predicting Pathologic Complete Response After Neoadjuvant Chemotherapy

What this Trial Is About

This research aims to compare two imaging methods, contrast-enhanced digital mammography combined with contrast-enhanced digital breast tomosynthesis (CEDM+CEDBT), and breast magnetic resonance imaging (MRI), to predict how well neoadjuvant chemotherapy works in treating early-stage and locally advanced breast cancer. The study focuses on how accurately these imaging techniques can forecast the complete pathological response after chemotherapy. The study is conducted during an early phase 1 trial and involves women diagnosed with invasive locally advanced breast cancer, including HER2-positive and triple-negative types. Participants will undergo CEDM+CEDBT imaging using a special device called Siemens MAMMOMAT, which produces both two-dimensional and three-dimensional images of the breast. This imaging will be done after every 4-6 cycles of neoadjuvant chemotherapy, up to two times before their primary breast surgery. Before each imaging session, a technician will inject a contrast agent through a vein (not through a chemotherapy port) to enhance image quality. The contrast agent used is Omnipaque, an FDA-approved iodinated solution. During the study, participants will have 1-2 mammograms during or after chemotherapy but before surgery. The research team will also collect information from medical records related to the cancer and treatment, as well as obtain leftover tissue samples from diagnostic biopsies and breast surgery. The study will measure the accuracy of CEDM+CEDBT in predicting chemotherapy effects immediately after surgery, within up to 24 weeks, and compare it to the standard MRI prior to surgery. Participation can last up to 18 weeks, with no masking or placebo involved.

Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer