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NCT Number: NCT06220214

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Stony Brook Breast Center

Stony Brook, New York, 11794, United States

Location status: Recruiting

Location contact

Alison Stopeck, MD

PRINCIPAL_INVESTIGATOR

Caterina Vacchi-Suzzi, PhD

CONTACT

[email protected]

631-216-2993

Hailiang Huang, PhD

CONTACT

[email protected]

Wei Zhao

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CEDM

Diagnostic Test

Contrast Enhanced Digital Mammography

CEDBT

Diagnostic Test

Contrast-Enhanced Digital Breast Tomosynthesis

Omnipaque 350mgI/mL Solution for Injection

Drug

Injection of an FDA approved iodinated contrast agent is required to undergo the imaging procedures. It is not the intent of the study to evaluate the contrast agent, but it will be administered at the time of experimental imaging.

Primary outcomes

  1. Accuracy of (CEDM+CEDBT) to predict NAC treatment effects

    Time frame: Immediately after definitive breast surgery, up to 24 weeks

    The ability of CEDM + CEDBT to predict pathologic complete response to neoadjuvant chemotherapy, determined by histopathology evaluation of the resected breast

Secondary outcomes

  1. Accuracy of (CEDM+CEDBT) to detect residual tumor compared with standard of care MRI

    Time frame: Immediately before definitive breast surgery

    Concordance between CEDM + CEDBT and standard of care MRI in quantifying residual tumor size

Study contacts

Contact information is provided by the study sponsor or research team.

Alison Stopeck, MD

CONTACT

[email protected]

631-444-7217

Caterina Vacchi-Suzzi, PhD

CONTACT

[email protected]

631-216-2993

Sponsors and collaborators

Lead sponsor

Alison Stopeck

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2024
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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