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

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

Recruiting
18 years and older
Female
Phase 0

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Overview

The purpose of this study is to compare a special type of mammogram that uses a contrast agent called contrast-enhanced digital mammography with contrast-enhanced digital breast tomosynthesis (CEDM+CEDBT), with breast magnetic resonance imaging imaging (MRI) for predicting the effect of neoadjuvant chemotherapy on pathologic complete response rates. The device used to obtain CEDM+CEDBT images is called Siemens MAMMOMAT. This device produces two-dimensional (2D) images, as in a normal mammogram, but also collects additional images for digital breast tomosynthesis (DBT), which produces a three-dimensional (3D) image of the breast in the form of image slices. DBT allows the radiologist to "see through" the breast tissue for better detection and localization of breast cancer. By looking at both the CEDM images and the CEDBT images, a radiologist may be able to better detect residual breast cancer in a more cost-effective manner.

Participation may last up to 18 weeks.

Study procedures for this research are:

  • Undergoing 1-2 mammograms during and/or after your chemotherapy, but before primary breast surgery.
  • Before each mammogram, have a radiology technician inject a liquid contrast agent by inserting a needle into a vein. The chemotherapy port cannot be used to receive the contrast agent
  • Let the research team record information from your medical record related to your condition and the treatment you receive.
  • Give permission to collect leftover tissue from your diagnostic biopsy and breast surgery.

Eligibility

Inclusion Criteria:

  • Diagnosis with either type of invasive locally advanced breast cancer regardless of hormone receptor or Her2 status
  • Plan to receive at least 4 cycles of neoadjuvant chemotherapy ahead of definitive surgery

Exclusion Criteria:

  • Pregnancy
  • Allergy/sensitivity to contrast agent
  • Decreased kidney function
  • Diabetes

Study details
    Breast Cancer
    Locally Advanced Breast Cancer
    Neoadjuvant Chemotherapy
    HER2-positive Breast Cancer
    Triple Negative Breast Cancer
    TNBC
    Triple Negative Breast Cancer

NCT06220214

Alison Stopeck

14 May 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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