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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAlison Stopeck

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Pregnancy

Allergy/sensitivity to contrast agent

Decreased kidney function

Diabetes

Trial design

Treatments tested in this trial

  • CEDM
  • CEDBT
  • Omnipaque 350mgI/mL Solution for Injection

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Alison Stopeck

Lead sponsor

Stony Brook University

Sponsor institution