← Back to Search

Contrast-Enhanced Mammography for Breast Abnormalities

Phase 4

Recruiting

Led By Margarita L Zuley, MD

Research Sponsored by Margarita Louise Zuley

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is ≥30 years old

Be older than 18 years old

Must not have

Subject is actively being treated for cancer of any type with chemotherapy

Subject has reduced kidney function with eGFR < 45.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up year 5

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether adding a contrast-enhanced mammography (CEM) procedure to the standard mammography procedure can reduce the number of times a biopsy is recommended for actually benign cases by at least 20%.

Who is the study for?

This trial is for women aged 30 or older with suspicious breast abnormalities scheduled for a biopsy. It's not suitable for pregnant or breastfeeding women, those on chemotherapy, with reduced kidney function (eGFR < 45), known allergies to iodinated contrast, or who have a breast implant in the affected breast.

What is being tested?

The study tests if Contrast-Enhanced Mammography (CEM) using Iodinated Contrast Media can reduce unnecessary biopsies in cases rated BI-RADS 4A/4B while maintaining high cancer detection rates. Participants will undergo CEM before their planned biopsy to evaluate its effectiveness.

What are the potential side effects?

Potential side effects may include reactions to the iodinated contrast used during CEM such as rash, itching, or more severe allergic responses. Kidney function might also be affected due to the contrast media.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 30 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently receiving chemotherapy for cancer.

Select...

My kidney function is low, with an eGFR below 45.

Select...

I cannot or do not want to give informed consent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ year 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~year 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and year 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Negative Predictive Value (NPV)

Secondary study objectives

Positive Predictive Value of biopsies performed (PPV3)

Other study objectives

Frequencies

Positive predictive value of biopsy recommendations (PPV2)

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: contrast enhanced mammographyExperimental Treatment2 Interventions

Women who have been recently diagnosed with a suspicious abnormality for which they have scheduled a breast biopsy and meet inclusion criteria will be invited to have a contrast enhanced mammography before their scheduled biopsy procedure.

0 / 4Eligibility criteria met