Actively Recruiting

Early Phase 1
Age: 18Years +
FEMALE
NCT06220214

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

Led by Alison Stopeck · Updated on 2026-01-15

30

Participants Needed

1

Research Sites

129 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Stony Brook Breast Center

Stony Brook, New York, United States, 11794

Actively Recruiting

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Research Team

A

Alison Stopeck, MD

CONTACT

C

Caterina Vacchi-Suzzi, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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