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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
Women with suspicious MADs recommended for a stereotactic biopsy who underwent their diagnostic imaging work-up resulting in a biopsy recommendation at MD Anderson Cancer Center (MDACC) or at an outside facility with a technically acceptable quality of diagnostic mammography, and who are planning to have their biopsy at MDACC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 β€œYes” for the criteria below
Select...
I am between 25 and 85 years old.
Select...
I am a woman advised to have a stereotactic biopsy for suspicious breast changes, planning to undergo it at MDACC.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Accuracy of contrast-enhanced mammography (CEM)
Secondary outcome measures
Cancer detection rate
Degree of enhancement on CEM
Noninfiltrating Intraductal Carcinoma
+4 more

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
~840
Contrast-Enhanced Mammography
2021
N/A
~90

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,256 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,247 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,343 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 β€” 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 β€” N/A
Contrast-Enhanced Mammography (Imaging Technology) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04871139 β€” N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum amount of participants allowable in this trial?

"Affirmative, clinicaltrials.gov indicates that enrollment for this study is ongoing. It was initially posted on April 8th 2021 and the most recent amendment to its description occured on May 1st 2021. This trial requires 100 patients at a single site."

Answered by AI

Can elderly individuals aged 65 and older be included in this medical experiment?

"As stipulated in the enrolment criteria for this trial, only individuals aged 25 and over, but no more than 85, are eligible to partake."

Answered by AI

Are there any current opportunities to enroll in this trial?

"Affirmative. The data hosted on clinicaltrials.gov reveals the ongoing nature of this medical study, which was first posted on April 8th 2021. 100 participants are needed from a single research centre."

Answered by AI

Who is eligible to join this medical experiment?

"This clinical evaluation is seeking 100 women between the ages of 25 and 85 who have been recommended for stereotactic biopsy due to suspicious MADs. Eligible candidates must be willing to partake in this study, receive an IV placement, endure iodinated contrast injection, and provide informed consent. In addition, they must either have had their diagnostic imaging done at MD Anderson Cancer Center or another facility that meets technical mammography criteria."

Answered by AI
~40 spots leftby Mar 2026