Recruiting
Early Phase 1

Neoadjuvant Therapy

Sponsor:

Alison Stopeck

Code:

NCT06220214

Conditions

Breast Cancer

Locally Advanced Breast Cancer

Neoadjuvant Chemotherapy

HER2-positive Breast Cancer

Triple Negative Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CEDM

CEDBT

Omnipaque 350mgI/mL Solution for Injection

Study Details

Brief summary:

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

Breast Cancer

Locally Advanced Breast Cancer

Neoadjuvant Chemotherapy

HER2-positive Breast Cancer

Triple Negative Breast Cancer

Study ID

NCT06220214

Start date

Mar 6, 2024

Status verified date

Dec, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: CEDM + CEDBT

Participants undergo CEDM + CEDBT imaging after every 4-6 cycles of neoadjuvant chemotherapy prior to surgery (imaging may occur up to 2 times)

Interventions

CEDM

Contrast Enhanced Digital Mammography

CEDBT

Contrast-Enhanced Digital Breast Tomosynthesis

Omnipaque 350mgI/mL Solution for Injection

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 outcome measure

  • Accuracy of (CEDM+CEDBT) to predict NAC treatment effects [ Time Frame: Immediately after definitive breast surgery, up to 24 weeks ]

Central Contacts and Locations

Locations

Stony Brook Breast Center

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Principal Investigator:

Alison Stopeck, MD

More Information

Sponsor

Alison Stopeck

Last update posted

Jan 15, 2026

Last verified

Dec, 2025

Keywords

  • cedm
  • cedbt
  • contrast-enhanced digital mammography
  • contrast-enhanced digital breast tomosynthesis
  • neoadjuvant chemotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alison Stopeck on 2026-01-15.