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CEDM + CEDBT for Breast Cancer

Phase < 1
Recruiting
Led By Alison Stopeck, MD
Research Sponsored by Alison Stopeck
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately before definitive breast surgery
Awards & highlights

Study Summary

This trial is comparing a special type of mammogram using contrast with breast MRI to see how well they predict the effect of chemotherapy on breast cancer. Participants will have mammograms and contrast agents injected before surgery

Who is the study for?
This trial is for individuals with early-stage, invasive breast cancer who are planning to undergo at least four cycles of neoadjuvant chemotherapy before surgery. Participants will have mammograms using a contrast agent during/after chemo but before surgery.Check my eligibility
What is being tested?
The study compares contrast-enhanced digital mammography (CEDM) and digital breast tomosynthesis (CEDBT) against MRI in predicting the effectiveness of pre-surgery chemotherapy on eliminating cancer cells.See study design
What are the potential side effects?
Potential side effects may include discomfort from needle insertion for the contrast agent, allergic reactions to the contrast medium, and exposure to low levels of radiation during mammography.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after definitive breast surgery, up to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after definitive breast surgery, up to 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Accuracy of (CEDM+CEDBT) to predict NAC treatment effects
Secondary outcome measures
Accuracy of (CEDM+CEDBT) to detect residual tumor compared with standard of care MRI

Trial Design

1Treatment groups
Experimental Treatment
Group I: CEDM + CEDBTExperimental Treatment3 Interventions
Participants undergo CEDM + CEDBT imaging after every 4-6 cycles of neoadjuvant chemotherapy prior to surgery (imaging may occur up to 2 times)

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Who is running the clinical trial?

Alison StopeckLead Sponsor
3 Previous Clinical Trials
180 Total Patients Enrolled
2 Trials studying Breast Cancer
180 Patients Enrolled for Breast Cancer
Alison Stopeck, MDPrincipal InvestigatorStony Brook Cancer Center
4 Previous Clinical Trials
170 Total Patients Enrolled
1 Trials studying Breast Cancer
30 Patients Enrolled for Breast Cancer
~20 spots leftby Jul 2026
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