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Imaging Technology

Contrast-Enhanced Mammography for Breast Cancer

N/A
Recruiting
Led By Olena Weaver
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
Age 25-85 years
Be older than 18 years old
Must not have
Renal insufficiency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a new imaging technology, contrast-enhanced mammography, can help predict breast cancer. The technology makes tissue and blood vessels more visible in scans, which may help doctors find suspicious areas of the breast to biopsy.

Who is the study for?
This trial is for women aged 25-85 who have suspicious breast abnormalities recommended for biopsy. Participants must be willing to undergo IV placement, iodinated contrast injection, and provide informed consent. They can't join if they've had allergic reactions to iodine contrast, recent breast surgery or biopsy at the site of interest, kidney issues, severe allergies to any substance, or are pregnant or breastfeeding within the last 6 months.
What is being tested?
The study is testing a new imaging method called contrast-enhanced mammography which uses an iodine-based dye to improve visibility in scans. It aims to see if this technique is better at detecting cancers not found by other tests and helps pinpoint areas in the breast that need a biopsy.
What are the potential side effects?
Potential side effects may include allergic reactions related to the iodine-based contrast used during mammography such as rash, itching or more serious responses like trouble breathing. There might also be discomfort from IV placement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 25 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My kidneys do not work well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Accuracy of contrast-enhanced mammography (CEM)
Secondary study objectives
Cancer detection rate
Degree of enhancement on CEM
Proportion of cases in which CEM changes the original target for a stereotactic biopsy
+2 more

Awards & Highlights

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 (iodine-based contrast, CEM)Experimental Treatment4 Interventions
Patients receive iodine-based contrast agent IV and the undergo CEM over 10-15 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Contrast-Enhanced Mammography
2021
N/A
~90

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,065 Previous Clinical Trials
1,802,148 Total Patients Enrolled
147 Trials studying Breast Cancer
63,073 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,365 Total Patients Enrolled
942 Trials studying Breast Cancer
1,443,237 Patients Enrolled for Breast Cancer
Olena WeaverPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
306 Total Patients Enrolled

Media Library

Contrast-Enhanced Mammography (Imaging Technology) Clinical Trial Eligibility Overview. Trial Name: NCT04871139 — N/A
Breast Cancer Research Study Groups: Diagnostic (iodine-based contrast, CEM)
Breast Cancer Clinical Trial 2023: Contrast-Enhanced Mammography Highlights & Side Effects. Trial Name: NCT04871139 — N/A
Contrast-Enhanced Mammography (Imaging Technology) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04871139 — N/A
~26 spots leftby Mar 2026
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