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CESM for Breast Cancer Detection

N/A

Recruiting

Led By Olena Weaver, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Women presenting to MDACC for the evaluation of PND as the main or accompanying symptom

Age 25-85 years

Must not have

Breast biopsy of the symptomatic breast within the last 2 months, if it was located within 5 cm from the nipple

Known breast cancer or active inflammatory process (such as abscess or mastitis) in the breast of concern

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial looks at using CESM to examine nipple discharge to see if it's more effective than standard mammography in detecting breast cancer.

Who is the study for?

This trial is for women aged 25-85 with abnormal nipple discharge, who can have an IV placed and tolerate iodine contrast. It's not for those who've had recent breast biopsies or surgery near the nipple, known breast cancer, inflammation in the breast, are pregnant or breastfeeding within 6 months, allergic to iodine contrast, severe allergies of any kind without prior safe iodine contrast use, or kidney issues.

What is being tested?

The study tests if Contrast Enhanced Spectral Mammography (CESM), which uses an injected dye to make scans clearer than standard mammograms, is more effective at diagnosing causes of nipple discharge and detecting breast cancer.

What are the potential side effects?

Potential side effects include reactions to the iodinated contrast agent used during CESM such as allergic reactions ranging from mild (itching, rash) to severe (trouble breathing), and possible kidney function impact.

Eligibility Criteria

Inclusion Criteria

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

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I am a woman seeking evaluation for nipple discharge as a primary or secondary symptom.

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I am between 25 and 85 years old.

Exclusion Criteria

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

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I had a breast biopsy near the nipple within the last 2 months.

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I have breast cancer or an active infection in my breast.

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I had breast surgery near the nipple within the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Sensitivity of contrast enhancement of contrast enhanced spectral mammography (CESM)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (CESM, DBT)Experimental Treatment4 Interventions

Patients receive iodine-based contrast agent IV then undergo CESM over 10-15 minutes. Patients who have not undergone standard of care DBT within 3 months from the study, also undergo DBT.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Contrast Enhanced Digital Mammography

2019

N/A

~570

Iodine

FDA approved

Digital Tomosynthesis Mammography

2017