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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
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 “Yes” for the criteria belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
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 moreTrial 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
3,002 Previous Clinical Trials
1,794,179 Total Patients Enrolled
148 Trials studying Breast Cancer
63,277 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,301 Total Patients Enrolled
944 Trials studying Breast Cancer
1,544,008 Patients Enrolled for Breast Cancer
Olena WeaverPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
306 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 25 and 85 years old.You have had a bad allergic reaction to iodine dye in the past.I am a woman advised to have a stereotactic biopsy for suspicious breast changes, planning to undergo it at MDACC.My kidneys do not work well.You had a breast biopsy in the same area within the last 2 months.I have not had breast surgery in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (iodine-based contrast, CEM)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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