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CESM for Breast Cancer Detection
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
Women presenting to MDACC for the evaluation of PND as the main or accompanying symptom
Age 25-85 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am a woman seeking evaluation for nipple discharge as a primary or secondary symptom.
Select...
I am between 25 and 85 years old.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sensitivity of contrast enhancement of contrast enhanced spectral mammography (CESM)
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
Digital Tomosynthesis Mammography
2017
N/A
~140
Iodine
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,986 Previous Clinical Trials
1,789,448 Total Patients Enrolled
148 Trials studying Breast Cancer
63,277 Patients Enrolled for Breast Cancer
Olena WeaverPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
340 Total Patients Enrolled
Olena Weaver, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
1,000 Total Patients Enrolled
1 Trials studying Breast Cancer
1,000 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidneys do not work properly.I had a breast MRI within the last 2 years before my current symptoms started.I had a breast biopsy near the nipple within the last 2 months.I have breast cancer or an active infection in my breast.You had a serious allergic reaction to a substance, except for iodine-based IV contrast that was given without any problems before.I am a woman seeking evaluation for nipple discharge as a primary or secondary symptom.You have had an allergic reaction to iodine-based dye in the past.I had breast surgery near the nipple within the last 6 months.I am between 25 and 85 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (CESM, DBT)
Awards:
This trial has 2 awards, including:- 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.
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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