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

This study is looking at a new way to see how well chemotherapy is working for early-stage breast cancer. It compares special mammograms called Contrast-Enhanced Digital Mammography (CEDM) and Contrast-Enhanced Digital Breast Tomosynthesis (CEDBT) with standard MRI scans. These special mammograms use an FDA-approved dye, Omnipaque 350mgI/mL Solution for Injection, to get clearer pictures. The goal is to see if CEDM+CEDBT can accurately predict how much the cancer shrinks after chemotherapy, before surgery. You may be able to join if you have locally advanced breast cancer and are planning to receive at least four cycles of chemotherapy before surgery. The study is currently unclear on its recruitment status and plans to enroll 30 women.

Study design
This is an interventional study with an unclear phase, planning to enroll 30 women. It compares two imaging methods to predict treatment effects.
What's involved
You would undergo the experimental imaging procedures, which require an injection of a contrast agent. These imaging procedures would occur immediately after definitive breast surgery.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, accuracy of the imaging, is measured immediately after definitive breast surgery, up to 24 weeks.

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NCT06220214

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalDiagnostic
Alison Stopeck
~30 participants
Updated 2026-01-15 on ClinicalTrials.gov
What's tested:CEDMCEDBTOmnipaque 350mgI/mL Solution for Injection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Accuracy of (CEDM+CEDBT) to predict NAC treatment effects
Measured over Immediately after definitive breast surgery, up to 24 weeks
Breast Cancer
Locally Advanced Breast Cancer
Neoadjuvant Chemotherapy
HER2-positive Breast Cancer
Triple Negative Breast Cancer
TNBC, Triple Negative Breast Cancer
1 sites across 1 states
New York1
  • Alison Stopeck, MD · PRINCIPAL_INVESTIGATOR · Stony Brook Cancer Center

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Pregnancy
Allergy/sensitivity to contrast agent
Decreased kidney function
Diabetes
  • Accuracy of (CEDM+CEDBT) to predict NAC treatment effectsImmediately 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